Manufacturer registered with FDA

ErgoDenta ApS

Taastrup, Denmark. Lists 26 dental device types with FDA across 1 registered establishment.

FDA owner/operator10094892Contract manufacturerManufacturerRepacker / relabeler

Device types listed: 26
Brands and models: 888
510(k) clearances: 0as applicant
Markets registered in: 44 registrations outside the US
Establishments: 1Denmark

Registered in 4 markets

Where regulators' registries name ErgoDenta ApS as the manufacturer or the registration holder of a device.

RegisteredHome: DenmarkOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	ErgoDenta ApS	26 device types	—	Below
European Union	EUDAMED	Manufacturer	ErgoDenta ApS	2	—	Pure Global AI
Israel	AMAR	Manufacturer	ErgoDenta ApS	1	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ErgoDenta Aps	1	2025–2025	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What ErgoDenta ApS currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	Double End steel Handle, 8mmErgoLite Mirror handle, Citrus OrangeErgoLite Mirror handle, Honey BrownErgoLite Mirror handle, Lemon GreenErgoLite Mirror handle, Lilac BlueErgoLite Mirror handle, Magenta BlueErgoLite Mirror handle, Misty CyanErgoLite Mirror handle, Petal PinkErgoLite Mirror handle, Pure BlackErgoLite Mirror handle, Ruby Pink 60 more ErgoLite Mirror handle, Sky CyanErgoSteel Mini, Mirror handleErgoSteel Plus, Mirror handleErgoSteel Standard, Mirror handleErgoX Mirror handle, Aqua LightErgoX Mirror handle, Citrus OrangeErgoX Mirror handle, Deep BlueErgoX Mirror handle, Earth BrownErgoX Mirror handle, Honey BrownErgoX Mirror handle, Lemon GreenErgoX Mirror handle, Lilac BlueErgoX Mirror handle, Magenta BlueErgoX Mirror handle, Misty CyanErgoX Mirror handle, Peach BlushErgoX Mirror handle, Petal PinkErgoX Mirror handle, Pure BlackErgoX Mirror handle, Ruby PinkErgoX Mirror handle, Sky CyanErgoX Mirror handle, Teal DeepErgoX Plus Mirror handle, Aqua LightErgoX Plus Mirror handle, Citrus OrangeErgoX Plus Mirror handle, Deep BlueErgoX Plus Mirror handle, Earth BrownErgoX Plus Mirror handle, Honey BrownErgoX Plus Mirror handle, Lemon GreenErgoX Plus Mirror handle, Lilac BlueErgoX Plus Mirror handle, Magenta BlueErgoX Plus Mirror handle, Misty CyanErgoX Plus Mirror handle, Peach BlushErgoX Plus Mirror handle, Petal PinkErgoX Plus Mirror handle, Pure BlackErgoX Plus Mirror handle, Ruby PinkErgoX Plus Mirror handle, Sky CyanErgoX Plus Mirror handle, Teal DeepFront-Surface Mouth Mirror, No. 3, 20mmFront-Surface Mouth Mirror, No. 4, 22mmFront-Surface Mouth Mirror, No. 5, 24mmHD Mouth Mirror, No. 4, 22mm, BlackHD Mouth Mirror, No. 4, 22mm, BlueHD Mouth Mirror, No. 4, 22mm, GreenHD Mouth Mirror, No. 4, 22mm, PinkHD Mouth Mirror, No. 5, 24mm , BlueHD Mouth Mirror, No. 5, 24mm, BlackHD Mouth Mirror, No. 5, 24mm, GreenHD Mouth Mirror, No. 5, 24mm, PinkMicroscopic HD Mouth Mirror, 2x7mm, Black, Regular 1.5mmMicroscopic HD Mouth Mirror, 2x7mm, Black, UltraThin 0.7mmMicroscopic HD Mouth Mirror, 3mm, Black, Regular 1.5mmMicroscopic HD Mouth Mirror, 3mm, Black, UltraThin 0.7mmMicroscopic HD Mouth Mirror, 3x9mm, Black, Regular 1.5mmMicroscopic HD Mouth Mirror, 3x9mm, Black, UltraThin 0.7mmMicroscopic HD Mouth Mirror, 5mm, Black, Regular 1.5mmMicroscopic HD Mouth Mirror, 5mm, Black, UltraThin 0.7mmMicroscopic HD Mouth Mirror, 7mm, Black, UltraThin 0.7mmOrtho 0-25 Mirror Handle, ErgoX Pro, Misty CyanOrtho 0-25 Mirror Handle, ErgoX, Misty CyanPlain Mouth Mirror, No. 3, 20mmPlain Mouth Mirror, No. 4, 22mmPlain Mouth Mirror, No. 5, 24mmSingle End steel Handle, 8mm	2026
Orthodontic Wire ClampECN · Class 1	—	Maker	Band PusherBand seater, Blue, 13cmBoons Gauge With LidBracket Positioning Tweezer, 14cmBracket Tweezer, 11cmBuccal Tube HolderLigature 17CLigature U15Measuring ruler, 0-60mmMeasuring ruler, 0-80mm 2 more Ortho Arch Wire TuckerOrtho Ligature Tucker	2026
Rubber Dam ClampEEF · Class 1	Rubber dam systems	Maker	Ainsworth Rubber Dam Punch, 17cmG27 - Molar rubber dam clamps (GENERAL)G27N - Pre molar rubberdam clampsIvory Rubber Dam Clamp Forceps, 17cmIvory Rubber Dam Punch Forceps, 16cmIvory Rubber Dam Punch Forceps, PartsK27N - Pre molar rubberdam clampsRubber Dam Clamp Forceps Brewer, 17cmRubber Dam Clamp Forceps Stockes, 17cmRubber Dam Clamp Forceps Washington, 17cm 55 more Rubber Dam Clamp Forceps White, 17cmRubber Dam Stand, 10cm x 11cmRubber Dam Stand, 9cm x 10cmW00 - Anterior Rubber Dam ClampsW12A - Lower molar rubber dam clampsW14 - Molar rubber dam clamps (GENERAL)W14A-Molar rubber dam clamps (GENERAL)W2 - Pre molar rubberdam clampsW3 - Lower molar rubber dam clampsW4 - Upper molar rubber dam clampsW7 - Lower molar rubber dam clampsW8 - Upper molar rubber dam clampsW8A - Molar rubber dam clamps (GENERAL)0 - Pre molar rubberdam clamps00 - Anterior Rubber Dam Clamps1 - Pre molar rubberdam clamps10 - Molar rubber dam clamps (GENERAL)11 - Molar rubber dam clamps (GENERAL)12A - Lower molar rubber dam clamps13A - Lower molar rubber dam clamps14 - Molar rubber dam clamps (GENERAL)14A - Molar rubber dam clamps (GENERAL)18 - Molar rubber dam clamps (GENERAL)1A - Pre molar rubberdam clamps2 - Pre molar rubberdam clamps201 - Upper molar rubber dam clamps205 - Upper molar rubber dam clamps209 - Pre molar rubberdam clamps212 - Anterior Rubber Dam Clamps212SA - Anterior Rubber Dam Clamps24 - Molar rubber dam clamps (GENERAL)25 - Molar rubber dam clamps (GENERAL)26 - Lower molar rubber dam clamps26N - Upper molar rubber dam clamps27 - Molar rubber dam clamps (GENERAL)27N - Pre molar rubberdam clamps28 - Lower molar rubber dam clamps29 - Pre molar rubberdam clamps2A - Pre molar rubberdam clamps2AS - Pre molar rubberdam clamps3 - Lower molar rubber dam clamps30 - Upper molar rubber dam clamps31 - Upper molar rubber dam clamps4 - Upper molar rubber dam clamps5 - Upper molar rubber dam clamps56 - Molar rubber dam clamps (GENERAL)56S - Molar rubber dam clamps (GENERAL)6 - Anterior Rubber Dam Clamps7 - Lower molar rubber dam clamps7A - Lower molar rubber dam clamps8 - Upper molar rubber dam clamps8A - Molar rubber dam clamps (GENERAL)8AD - Molar rubber dam clamps (GENERAL)9 - Anterior Rubber Dam Clamps9S - Anterior Rubber Dam Clamps	2026
Dental Surgical Tissue ScissorsEGN · Class 1	Dental hand instruments	Maker	All Round Surgery KitBarraquer/Gingiva Scissor, Straight, 13cm, TCBarraquer/Gingiva Scissor, Straight, 15cm, TCGoldman Fox, Curved, 13 cm, Black, Super-cut, TCGoldman Fox, Curved, 13 cm, Super-cutGoldman Fox, Curved, 13cmGoldman Fox, Curved, 13cm, TCGoldman Fox, Straight, 13 CM, Black, Super-cut, TCGoldman Fox, Straight, 13 CM, Super-cutGoldman Fox, Straight, 13cm 30 more Goldman Fox, Straight, 13cm, TCJoseph Scissor, Curved, 14.5cm, TCKelly Scissor, Curved, 16cmKelly Scissor, Straight, 16cmKelly Scissor, Straight, 16cm, TCKilner Scissor, Straight, 12.5cmMayo Scissor, Curved, 14.5cmMayo Scissor, Curved, 14.5cm, TCMayo Scissor, Curved, 18cmMayo Scissor, Curved, 18cm, TCMayo Scissor, Straight, 14.5cmMayo Scissor, Straight, 14.5cm, TCMayo Scissor, Straight, 18 cmMayo Scissor, Straight, 18cm, TCMetzenbaum Fino Scissor, Curved, 14.5cm, TCMetzenbaum Fino Scissor, Straight, 14.5cm, TCMetzenbaum Open Scissor, Straight, 14.5cm, TCMetzenbaum Sahrp Scissor, Curved, 14.5cmMetzenbaum Sharp Scissor, Curved, 14.5cm, TCMetzenbaum Sharp Scissor, Straight, 14.5cmMetzenbaum Sharp Scissor, Straight, 14.5cm, TCMetzenbaum Stump Scissor, Curved, 14.5cm, TCMetzenbaum Stump Scissor, Curved, 14.5cm.Metzenbaum Stump Scissor, Straight, 14.5cmMetzenbaum Stump Scissor, Straight, 14.5cm, TCMicro Surgery KitMicrosurgical Scissor, Curved, 14.5cm,TCMicrosurgical Scissor, Straight, 14.5cm,TCNoyes Scissor, Curved, 15cmNoyes Scissor, Straight, 15cm	2026
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	Half Non-Perforated Impression Tray, LeftHalf Non-Perforated Impression Tray, RightHalf Perforated Impression Tray, LeftHalf Perforated Impression Tray, RightNon-Perforated Impression Tray, Lower Jaw, Extra LargeNon-Perforated Impression Tray, Lower Jaw, Extra SmallNon-Perforated Impression Tray, Lower Jaw, LargeNon-Perforated Impression Tray, Lower Jaw, MediumNon-Perforated Impression Tray, Lower Jaw, SmallNon-Perforated Impression Tray, Upper Jaw, Extra Large 14 more Non-Perforated Impression Tray, Upper Jaw, Extra SmallNon-Perforated Impression Tray, Upper Jaw, LargeNon-Perforated Impression Tray, Upper Jaw, MediumNon-Perforated Impression Tray, Upper Jaw, SmallPerforated Impression Tray, Lower Jaw, Extra LargePerforated Impression Tray, Lower Jaw, Extra SmallPerforated Impression Tray, Lower Jaw, LargePerforated Impression Tray, Lower Jaw, MediumPerforated Impression Tray, Lower Jaw, SmallPerforated Impression Tray, Upper Jaw, Extra LargePerforated Impression Tray, Upper Jaw, Extra SmallPerforated Impression Tray, Upper Jaw, LargePerforated Impression Tray, Upper Jaw, MediumPerforated Impression Tray, Upper Jaw, Small	2026
Irrigating Endodontic Periodontic SyringeEIC · Class 1	Dental hand instruments	Maker	Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric ThreadCylinder Cartridge Syringe, 1.8 ml, Chrome-plated, with Metric Thread, without aspirationCylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, with aspirationCylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, without aspirationPen Model Intraligamental Syringe, 1.8 ml, 07 ml/ click, with Metric Thread"Pen Model Intraligamental Syringe, Angled, 1.8 ml, 07 ml/ click, with Metric ThreadPistol Model Syringe, 1.8 ml, 0.2 ml/ click, with Metric Thread"Plastic Pipe for Pistol SyringeSelf Aspirating Syringe, Brass, 1.8 ml, with Metric ThreadSelf Aspirating Syringe, Plastic and Metal, 1.8 ml, with Metric Thread 1 more Self Aspirtning Syringe, Plastic and Metal, 2.2 ml, with Metric Thread	2026
All Types RetractorEIG · Class 1	Dental hand instruments	Maker	Bowdler Henry Retractor, 16cmCawood-Minnesota, 2x16cm, 15.5cmFarabeuf Retractor, Set of 2 pcs, 12cm Fig. 1, 26 x 10 mm / 30 x 13 mm Fig. 2, 30 x 10 mm / 34 x 13 mmLangenbeck Retractor, 29 x 10 mm, 22cmLangenbeck Retractor, 42 x11 mm, 22cmLangenbeck Retractor, 60 x11 mm, 22cmMiddeldorpf Retractor, Medium, 20 x 22 mm, 21cmMiddeldorpf Retractor, Small, 14 x 17 mm, 21cmObwegeser External Retractor, 31 x 10 mm, 23cmObwegeser External Retractor, 40 x 11 mm, 23cm 11 more Obwegeser External Retractor, 70 x 14 mm, 23cmObwegeser Internal Retractor, 32 x 10 mm, 23cmObwegeser Internal Retractor, 42 x 10 mm, 23cmObwegeser Internal Retractor, 55 x 12 mm, 23cmPeriodontal Surgery KitS-retractorSean-Miller Retractor,Sean-Miller Retractor, SharpUniversal cheek retractorUniversal Cheek Retractor, 14cmWassmund Retractor, 30 x 20 mm, 22cm	2026
Crown RemoverEIS · Class 1	Dental hand instruments	Maker	Changeable parts for Crown Tractor Plier, 20 Spare silicone padsCrown Remover PlierCrown Remover with three tipsCrown Removing Forceps, Curved, 17cm, TCCrown Scissor, BeeBee, Saw Edge, Curved, 13cmCrown Scissor, BeeBee, Saw Edge, Straight, 13cmCrown Scissor, Straight, 11.5cmCrown Spreader Plier, 15cmCrown Tractor Plier, with spare 20 silicone padsGutta Percha Remover, Left-Right, 0.4mm Hook 5 more Gutta Percha Remover, Up-Down, 0.4mm HookLindblom crown Remover PlierMiller Crown Remover, with 4 tipsUniversal Crown Scissor, Saw Edge, For wire cut, Angled, 12.5cmUniversal Crown Spreader	2026
Periodontic ProbeEIX · Class 1	Dental hand instruments	Maker	CP Probe 15 (1-15mm)Explorer 17Explorer 17-9Explorer 17C-23Explorer 23Explorer 29Explorer 2AExplorer 33Explorer 3AExplorer 5 30 more Explorer 5-8Explorer 5-9Explorer 8Explorer 9Explorer-HolstFurcation ProbeNabers ProbeNabers Probes (ball-end)Probe 11Probe 12Probe 12BProbe 15Probe 18Probe 2Probe 2BProbe CP 11Probe CP 11 (3-6-8-11mm)Probe CP 12 (3-6-9-12mm)Probe CP 12B (Ball-end)Probe CP 18Probe CP 2Probe CP 2 (2-4-6-8-10-12mm)Probe CP 2B (Ball-end) (2-4-6-8-10-12mm)Probe WHO 11.5mm (Ball End)Weston ExplorerWHO ProbeWHO Probe 11.5mmWilliam ProbeWilliam Probe 2-4-6-8-10mmWilliam Probe 3-5-8-11mm	2026
Dental Plastic Filling InstrumentEIY · Class 1	Dental hand instruments	Maker	Amalgam Condenser, 1mm-1.5mmAmalgam Condenser, 2mm-2.5mmBase Carrier - Condenser Malleable TipBase Carrier - Condenser RigidBase Carrier - RigidBurnisherBurnisher & Plugger 1.5-2.5mmBurnisher & Plugger Ball end, 1.5-2.5mmBurnisher & Plugger, 1.4mm-1.8mmBurnisher & Plugger, 1.9mm-2.3mm 68 more Burnisher & Plugger, Ballended, 1.5mm-2.5mmBurnisher & Spatel, 1.5mm-2mmBurnisher 1.75-2.25 mmBurnisher, 1.75mm-2.25mmBurnisjer 1.75-2.25mmCarver 5Carver-Nystrøm ICarver-Nystrøm IIICement SpatelCement Spatula, 5mm-5mmCement Spatula, 6mm-6mmCement Spatula, 7mm-7mmComposite Instrument Posterior, 2.2mm-2.5mmComposite Spatul;a 6mmComposite Spatula 6Composite Spatula 6, 2.5mm-2.5mmComposite Trimmer, 1.5mm-2mmCondenser, Drop-Shaped, 1.3mm-1.8mmCord Packer 2 mmCord Packer, 2.6mmCord Packer, 2mmFilling ApplicatorFilling CondensorFilling ContourFilling Instrument-C49Filling Instrument-PFI 6Filling Instrument-PFI 8AFilling Instrument-PFI UP1Filling Instrument-UP1Filling RemoverFilling ShaperFissureFlow Instrument IOForm Condenser, 1.5mm-2.5mmForm CondensorGingival Margin Trimmer, 1.2mm, DistalGingival Margin Trimmer, 1.2mm, MesialHeidemann, 2.5mmHeidemann, 2mmHeidemann, 3mmKnife-CarverMini SpatulaMini Spatula, 2mm-2mmModeller MhModeller MH MiniNystrom INystrom IIIPacker-Modeller IOPlastic Instrument (Anterior)Plastic Instrument (Posterior)Plastic Instrument-AnteriorPlastic Instrument-PosteriorPlugger Clubbed, 1.4mm-1.8mmPlugger FlatPlugger, 0.7mm-1mmPlugger, 1.3mm-1.6mmPlugger, 1.3mm-1.8mmPlugger, 1mm-1.3mmPlugger, 1mm-2mmPlugger, 2.5mm-3.8mmPlugger, 2mm-2.5mmPlugger, Cylindrical, 1.2mm-2mmPlugger, Cylindrical, 1.8mm-2.5mmPlugger, Cylindrical, 1mm-1.5mmRetraction Cord Paker-UP1Special Filling Instrument, 2mm-2.5mmUniversal Spatula, 1.5mm-2mmUP1 Plastic filling	2026
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Maker	Ergo LX - ErgoTip handle, Single-end, Aqua lightErgo LX - ErgoTip handle, Single-end, BlackErgo LX - ErgoTip handle, Single-end, GreyErgo LX - ErgoTip handle, Single-end, Lemon GreenErgo LX - ErgoTip handle, Single-end, Magenta BlueErgo LX - ErgoTip handle, Single-end, OrangeErgo LX - ErgoTip handle, Single-end, RedErgo LX - ErgoTip handle, Single-end, YellowErgo X - ErgoTip handle, Aqua lightErgo X - ErgoTip handle, Black 16 more Ergo X - ErgoTip handle, GreyErgo X - ErgoTip handle, Lemon GreenErgo X - ErgoTip handle, Magenta BlueErgo X - ErgoTip handle, OrangeErgo X - ErgoTip handle, RedErgo X - ErgoTip handle, YellowErgo X Plus - ErgoTip handle, Aqua lightErgo X Plus - ErgoTip handle, BlackErgo X Plus - ErgoTip handle, GreyErgo X Plus - ErgoTip handle, Lemon GreenErgo X Plus - ErgoTip handle, Magenta BlueErgo X Plus - ErgoTip handle, OrangeErgo X Plus - ErgoTip handle, RedErgo X Plus - ErgoTip handle, YellowErgoTip Double End steel Handle, 8mmErgoTip Single End steel Handle, 8mm	2026
Operative ExplorerEKB · Class 1	Dental hand instruments	Maker	Endo ExplorerExplorer 23 + Probe CP 12Explorer 23 + Probe CP 12BExplorer 23 + Probe CP 15Explorer 23 + Probe CP 2Explorer 23 + Probe CP 2BExplorer 6 + Probe CP 2Explorer 6L + Probe CP 15Explorer 8 + Probe CP 15Explorer 8 + Probe CP 2 12 more Explorer 8 + Probe CP 2BExplorer 8 + WHO ProbeExplorer 9 + Probe CP 18Explorer Holst + Probe CP 18Exprlorer 23 + WHO ProbeExpros 23 - Probe CP 2Expros 23- Probe CP 2Expros 23- WHO Probe CP, (ball-end)Expros 8- Probe CP 2 (baExpros 8- WHO Probe CP (ball-end)Probe William + Explorer HolstRoot Canal Explorer	2026
Operative Dental ExcavatorEKC · Class 1	Dental hand instruments	Maker	Action Excavator 1.5mmAction Excavator 1mmAction Excavator 2mmAction Excavator, 1.5mmAction Excavator, 1mmAction Excavator, 2mmAction Excavator, 3.5mmPeriotome 1, Curved / Straight, 2.2mm-2.2mmPeriotome 2, Curved / Curved, 2.2mm-2.2mmPeriotome Anterior, 2mm-3.4mm 19 more Periotome Posterior, 1.4mm-1.4mmRound Excavator 1.5mmRound Excavator 1mmRound Excavator 2mmRound Excavator, 1.5mmRound Excavator, 1.7mmRound Excavator, 1mmRound Excavator, 2.5mmRound Excavator, 2mmRound Excavator, 3mmRound Excavators 1.5mmRound Excavators 2.5mmRound Excavators 2mmSpoon Excavator, 1.3mmSpoon Excavator, 1.5mmSpoon Excavator, 1.7mmSpoon Excavator, 1mmSpoon Excavator, 2.5mmSpoon Excavator, 2mm	2026
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1	Dental hand instruments	Maker	Endo Spreader 0.4mm & Plugger 0.4mmEndo Spreader 0.4mm & Plugger 0.6mmEndo Spreader 0.6mm & Plugger 0.8mmEndo Spreader 0.6mm & Plugger 1mmEndo Spreader- 1SEndo Spreader- 2SEndo Spreader- 3SEndo Spreader- 4SEndo Spreader- 5SEndo Spreader- 6S 1 more Endo Spreader- 7S	2026
Endodontic Root Canal PluggerEKR · Class 1	Dental hand instruments	Maker	Endo Plugger, 0.5mm-1mmEndo Spreader 0.4mm & Plugger 0.4mmEndo Spreader 0.4mm & Plugger 0.6mmEndo Spreader 0.6mm & Plugger 0.8mmEndo Spreader 0.6mm & Plugger 1mmRoot Canal Stopper 0.5mmRoot Canal Stopper 0.6mmRoot Canal Stopper 0.7mmRoot Canal Stopper 0.9mmRoot Canal Stopper 1.2mm	2026
Surgical Tooth Extractor ForcepsEMG · Class 1	Dental hand instruments	Maker	Child Diamond extraction forceps Kit, 7pcsChild extraction forceps kit, 7pcsDiamond extraction forceps Kit, 10pcsFig. 1. Upper Incisors And MolarsFig. 13. Lower CuspidsFig. 137, Upper IncisorFig. 139, Upper Pre MolarFig. 13K Premolars, Lower JawFig. 144. Upper RootsFig. 17. Upper Molars, Right 41 more Fig. 18. Upper Molars, LeftFig. 22. Lower MolarsFig. 22K Molars, Lower JawFig. 23. Lower Molars, RightFig. 24. Lower Molars, LeftFig. 29. Upper FrontFig. 3 Upper MolarFig. 30S. Upper FrontFig. 33A. Lower IncisorsFig. 37 Incisors, Upper JawFig. 38 Incisors & Canins, Lower JawFig. 41. Upper RootsFig. 46. Upper RootsFig. 5, Lower IncisiverFig. 51S, Upper RootsFig. 6, Lower MolarFig. 67A. Upper MolarsFig. 7, Lower RootsFig. 7. Upper PremolarsFig. 74. Lower RootsFig. 79. Lower Wisdom TeethsFig. 86. Lower MolarsFig. 86A. LowerFig. 86A. Lower MolarsFig. 86B. LowerFig. 87. LowerFig. 97. Upper RootsFig. 98. Witzel (Upper roots)Fig. 99. Hertz (Lower Molars)Lower AnteriorLower MolarLower Spade RootLower UniversalStandard extraction forceps Kit, 10pcsUniversal-Lower RootsUniversal-Upper RootsUpper AnteriorUpper Jaw-MolarsUpper MolarUpper Spade RootUpper Universal	2026
Dental Surgical ElevatorEMJ · Class 1	Dental hand instruments	Maker	Apical Root Elevator, Fig. 302, 3.2mmApical Root Elevator, Fig. 303, 3.3mmApical Root Elevator, Straight, Fig. 301, 3mmAppexo Elevator, Curved, 2.5X9mmAppexo Elevator, Curved, 2.7X9mmAppexo Elevator, Curved, 3X9mmAppexo Elevator, Straight, 2.5X9mmAppexo Elevator, Straight, 2.7X9mmAppexo Elevator, Straight, 3X9mmBein Root Elevator, Straight, Fig. 1, 2.3mm 102 more Bein Root Elevator, Straight, Fig. 2, 3.2mmBein Root Elevator, Straight, Fig. 3, 4.1mmBernerd Elevator, AngledBernerd Elevator, StraightBerten Elevator, AngledBerten Elevator, CurvedBerten Elevator, StraightBone Scrapper, 3mm-5mmBuser, 4mm-4mmCryer Root Elevator, Fig. 27, 11.2mmCryer Root Elevator, Fig. 28, 11.2mmErgoLite Elevator Gold, Contra Curved 3mmErgoLite Elevator Gold, Curved, 3mmErgoLite Elevator Gold, Curved, 5mmErgoLite Elevator Gold, Duel Edge, 3mm-1.5mmErgoLite Elevator Gold, Duel Edge, 5mm-3mmErgoLite Elevator Gold, Inner Curved, 3mmErgoLite Elevator Gold, Straight, 1mmErgoLite Elevator Gold, Straight, 2mmErgoLite Elevator Gold, Straight, 3mmErgoLite Elevator Gold, Straight, 5mmErgoLite elevator, Contra Curved 3mmErgoLite elevator, Curved, 3mmErgoLite elevator, Curved, 5mmErgoLite elevator, Duel Edge, 3mm-1.5mmErgoLite elevator, Duel Edge, 5mm-3mmErgoLite elevator, Inner Curved, 3mmErgoLite elevator, Straight, 1mmErgoLite elevator, Straight, 2mmErgoLite elevator, Straight, 3mmErgoLite elevator, Straight, 5mmFlohr Root Elevator, Left, 3mmFlohr Root Elevator, Right, 3mmFreer, 5mm-5mmGlickmann, 4mm-4mmHeidbrink Root Tip Scaler, Left, 1.5mmHeidbrink Root Tip Scaler, Left, 2.5mmHeidbrink Root Tip Scaler, Right, 1.5mmHeidbrink Root Tip Scaler, Right, 2.5mmHeidbrink Root Tip Scaler, Straight, 1.5mmHeidbrink Root Tip Scaler, Straight, 2.5mmHeiderbrink Root Tip Elevator, Left, Fig. 3, 2.5mmHeiderbrink Root Tip Elevator, Right, Fig. 2, 2.5mmHeiderbrink Root Tip Elevator, Straight, Fig. 1, 2.5mmHylin Root Elevator, Straight, 4mmHylin Root Elevator, Straight, Fig. 1, 3.5mmHylin Root Elevator, Straight, Fig. 2, 4.5mmKopp Elevator, Lower Roots, Left, 4.2mmKopp Elevator, Upper Roots, Edge Sharp, 3.6mmKopp Elevator, Upper Roots, Edge Sharp, 4.2mmKopp Elevator, Upper Roots, Right, 4.2mmKopp Elevator, Upper Roots, Round Sharp, 3.6mmKopp Elevator, Upper Roots, Round Sharp, 4.2mmLindo-Levian Root Elevator, Fig. 1, 2.5mmLindo-Levian Root Elevator, Fig. 1, 3.5mmLindo-Levian Root Elevator, Fig. 3, 4mmLuxating Elevator Gold, Curved,Luxating Elevator Gold, Curved, 2.5mmLuxating Elevator Gold, Curved, 3mmLuxating Elevator Gold, Curved, 4mmLuxating Elevator Gold, Curved, 5mmLuxating Elevator Gold, Straight,Luxating Elevator Gold, Straight, 2.5mmLuxating Elevator Gold, Straight, 3mmLuxating Elevator Gold, Straight, 4mmLuxating Elevator Gold, Straight, 5mmLuxating Elevator, Curved, 2.5mmLuxating Elevator, Curved, 3mmLuxating Elevator, Curved, 4mmLuxating Elevator, Curved, 5mmLuxating Elevator, Straight, 2.5mmLuxating Elevator, Straight, 3mmLuxating Elevator, Straight, 4mmLuxating Elevator, Straight, 5mmMicro Surgery Periosteal Elevator, 1.8mm-2.8mmMicro Surgery Periosteal Elevator, 2.5mm-4mmMiller 21, 3mmMini Glickman, 3mm-3mmMolt 5mm-8mmNordberg Molt 4mm-7mmNordberg Molt 5mm-8mmPrichard, 5mm-11mmWidman Knives, CurvedWidman Knives, StraightWinter Elevator Root Elevator, Fig. 11L, 9.5mmWinter Elevator Root Elevator, Fig. 11R, 9.5mmX Tool Luxating elevator: Complete Set With CassetteX Tool-Bernard Spade Elevators Complete SetX Tool-Bernard Spade Elevators, Angled, LeftX Tool-Bernard Spade Elevators, Angled, RightX Tool-Bernard Spade Elevators, CurvedX Tool-Bernard Spade Elevators, External CurvedX Tool-Bernard Spade Elevators, Internal CurvedX Tool-Bernard Spade Elevators, StraightX Tool-Luxating Elevator, Curved, 2.6mmX Tool-Luxating Elevator, Distal, 2.6mmX Tool-Luxating Elevator, Mesial, 2.6mmX Tool-Luxating Elevator, Mesial, 4mmX Tool-Luxating Elevator, Spade, 3.5mmX Tool-Luxating Elevator, Spade, 4mmX Tool-Luxating Elevator, Straight, 2.6mmZucchelli 3mm-3mm	2026
Dental Surgical CuretteEMK · Class 1	Dental hand instruments	Maker	Hemingway 2, 2.8mmHemingway-1, 2.Hemingway-1, 2mmHemingway-3, 3.5mmHemingway, 2.6mmLucas 84, 1.5mmLucas 84, 2mmLucas 85, 2.5mmLucas 85, 2mmLucas 86, 2.5mm 7 more Lucas 86, 3mmLucas 87, 3.5mmLucas 87, 3mmLucas 88, 4mmMiller 8, 3.5mmSoft Tissue Curette: LeftSoft Tissue Curette: Right	2026
Surgical Osteotome ChiselEMM · Class 1	Dental hand instruments	Maker	Bone Spreader (set of 6 including hammer & cassette)Condenser Offset (Set of 7 including hammer & cassette)Condenser Straight (Set of 7 including hammer & cassette)Osteotome Offset (set of 5 including hammer & cassette)Osteotome Straight (set of 5 including hammer & cassette)	2026
Periodontic ScalerEMN · Class 1	Dental hand instruments	Maker	Crane-KaplanFurcator ScalerHoe Scaler, AnteriorHoe Scaler, LateralHoe Scaler, PosteriorM23M23AMicro Sickle 01-02Micro Sickle ScalerMicro Sickle Scaler 01 58 more Micro Sickle Scaler 02Mini Excess ScalerMini Sickle 11-12Mini Sickle ScalerMini Sickle Scaler 11Mini Sickle Scaler 12Nebraska 128Razor Black Micro Sickle Scaler 01Razor Black Micro Sickle Scaler 02Razor Black Mini Sickle Scaler 11Razor Black Mini Sickle Scaler 12Razor Black Sickle Scaler 204S (A)Razor Black Sickle Scaler 204S (B)Razor Black Sickle Scaler 204SD (A)Razor Black Sickle Scaler 204SD (B)Razor Black Sickle Scaler H6Razor Black Sickle Scaler H7Razor Black Sickle Scaler M23 (A)Razor Black Sickle Scaler M23 (B)Razor Gold Micro Sickle Scaler 01Razor Gold Micro Sickle Scaler 02Razor Gold Mini Sickle Scaler 11Razor Gold Mini Sickle Scaler 12Razor Gold Sickle Scaler 204S (A)Razor Gold Sickle Scaler 204S (B)Razor Gold Sickle Scaler 204SD (A)Razor Gold Sickle Scaler 204SD (B)Razor Gold Sickle Scaler H6Razor Gold Sickle Scaler H7Razor Gold Sickle Scaler M23 (A)Razor Gold Sickle Scaler M23 (B)Razor Micro Sickle Scaler 01Razor Micro Sickle Scaler 02Razor Mini Sickle Scaler 11Razor Mini Sickle Scaler 12Razor Sickle Scaler 204S (A)Razor Sickle Scaler 204S (B)Razor Sickle Scaler 204SD (A)Razor Sickle Scaler 204SD (B)Razor Sickle Scaler H6Razor Sickle Scaler H7Razor Sickle Scaler M23 (A)Razor Sickle Scaler M23 (B)Sharp Jack ScalerSickle Scaler 204SSickle Scaler 204S (A)Sickle Scaler 204S (B)Sickle Scaler 204SDSickle Scaler 204SD (A)Sickle Scaler 204SD (B)Sickle Scaler H6Sickle Scaler H6-H7Sickle Scaler H7Sickle Scaler M23Sickle Scaler M23 (A)Sickle Scaler M23 (B)Sickle Scalers 204SSickle Scalers 204SD	2026
Periodontic KnifeEMO · Class 1	Dental hand instruments	Maker	Kirkland	2026
Periodontic CuretteEMS · Class 1	Dental hand instruments	Maker	Barnhart 1-2Barnhart 5-6Columbia 13-14Columbia 2L-2RColumbia 4L-4RDuplex AnteriorDuplex CuretteGoldman-Fox 3Gracey 1Gracey 1-2 94 more Gracey 11Gracey 11-12Gracey 11-14Gracey 12Gracey 12-13Gracey 13Gracey 13-14Gracey 14Gracey 15-16Gracey 17-18Gracey 2Gracey 3-4Gracey 5Gracey 5-6Gracey 6Gracey 7Gracey 7-8Gracey 8Gracey 9-10Gracey P3-P4Langer 1-2Langer 3-4Langer 5-6Mccall 13S-14SMcCall 17-18McCall 17S-18SMini Duplex AnteriorMini Duplex CuretteMini Gracey 1Mini Gracey 1-2Mini Gracey 11Mini Gracey 11-12Mini Gracey 12Mini Gracey 13Mini Gracey 13-14Mini Gracey 14Mini Gracey 15-16Mini Gracey 17-18Mini Gracey 2Mini Gracey 7-8Mini Langer 1-2Mini Langer 3-4Mini Langer 5-6Mini McCall 13S-14SRazor Black Gracey 1Razor Black Gracey 11Razor Black Gracey 12Razor Black Gracey 13Razor Black Gracey 14Razor Black Gracey 2Razor Black Gracey 5Razor Black Gracey 6Razor Black Gracey 7Razor Black Gracey 8Razor Black Mini Gracey 1Razor Black Mini Gracey 11Razor Black Mini Gracey 12Razor Black Mini Gracey 13Razor Black Mini Gracey 14Razor Black Mini Gracey 2Razor Gold Gracey 1Razor Gold Gracey 11Razor Gold Gracey 12Razor Gold Gracey 13Razor Gold Gracey 14Razor Gold Gracey 2Razor Gold Gracey 5Razor Gold Gracey 6Razor Gold Gracey 7Razor Gold Gracey 8Razor Gold Mini Gracey 1Razor Gold Mini Gracey 11Razor Gold Mini Gracey 12Razor Gold Mini Gracey 13Razor Gold Mini Gracey 14Razor Gold Mini Gracey 2Razor Gracey 1Razor Gracey 11Razor Gracey 12Razor Gracey 13Razor Gracey 14Razor Gracey 2Razor Gracey 5Razor Gracey 6Razor Gracey 7Razor Gracey 8Razor Mini Gracey 1Razor Mini Gracey 11Razor Mini Gracey 12Razor Mini Gracey 13Razor Mini Gracey 14Razor Mini Gracey 2Rigid Gracey 11-12Rigid Gracey 13-14	2026
Matrix RetainerJEP · Class 1	Dental hand instruments	Maker	Ivory, 5mmNystrom, LeftNystrom, Left, CoatedNystrom, RightNystrom, Right, CoatedTofflemire, JuniorTofflemire, SeniorTofflemire, Universal	2026
Oral Hygiene Rubber TipJEW · Class 1	Floss & interdental cleaners	Maker	Wrench for ErgoTip	2026
Orthodontic PlierJEX · Class 1	Dental hand instruments	Maker	Adams Plier, max 0.4mm, Lap joint, 13cmAderer Plier, Long. max 0.6mm, 13cmAderer Plier, Short. max 0.6mm, 11.5cmAdhesive Removal PlierAngle Plier, max 0.7mm, Box Joint, 12.5cmAngle Plier, max 0.7mm, Lap Joint, 12.5cmBracket Removal PlierBracket Removing Plier, 12.5cmChangeable Part for Adhesive Removal Plier, BladeChangeable Part for Adhesive Removal Plier, Teflon 32 more Changeable Part for Posterior Band Removing Plier, Plastic PadCinch BackDe la rosa band contouringDiamant/Telescopic Crown Plier, 13cmDistal End Cutter, 12cm, TCDistal End Wirecutter Max. 0.55mm- 0.64-12.5 CMHard wire cutter, 10º Angle, 14cm, TCHOW Plier, Straight, 14cmLangback Plier, max 0.8mm, 12cmLigature CutterMathieu Ortho plierMicro ligature cutterNose Pliers, Long, 15cmNose Pliers, Short, 15cmPin & Ligature Wirecutter, max 0.5mm, 13cm, TCPin & Ligature Wirecutter, max 0.7mm, 13cmPin & Ligature Wirecutter, max 0.7mm, 13cm, TCPosterior Band Removing Plier, Long, With Teflon/Plastic Tip, 15cm, TCRibbon-Tweed arch, ShortRibbon-weed arch, LongSchwarz, Fig. 1, max 0.4mm, 13 CMSeparating Plier for an Easy Placement of Separating Elastics, 15cmThree beak PlierTweed Loop Plier, 13cmTweed Wire Bending Plier, 13cmTweed, max 0.5mm, Short, 12.5cmUniversal Plier, TCWeingart Plier for Dental Technic, 15cm, TCWeingart Plier Standard, for Dental Technic, 15cmWire Cutter, max 0.6mm, 12cmWire Cutter, max 0.6mm, 12cm, TCWire Cutter, max 1mm, 15cm	2026
Tongue ScraperLCN · Class 1	—	Maker	Bone Scrapper, 3mm-5mmHoward 67Howard 67- Straight cutTongue holderTongue holder - Minnesota 2cm x 14cm	2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

Establishment	Location	What it does
ERGODENTA APSFDA reg. 3043047788	Taastrup Hovedstaden, Denmark	Contract manufacturer, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094892). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.