Manufacturer registered with FDA
Directa AB
UPPLANDS VASBY, Sweden. Lists 30 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 30
- Brands and models
- 73
- 510(k) clearances
- 12015–2015
- Markets registered in
- 8122 registrations outside the US
- Establishments
- 1Sweden
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Directa AB as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Directa AB | 1 clearances | 2015–2015 | Below |
| United Kingdom | MHRA | Manufacturer | Directa AB | 42 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Directa AB | 28 | 2005–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DIRECTA ABDirecta AB | 21 | 2006–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Directa ABDIRECTA AB | 19 | 2006–2020 | Pure Global AI |
| Israel | AMAR | Manufacturer | Directa AB | 6 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Directa AB | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DIRECTA AB | 1 | 2015–2015 | 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 Directa AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Calasept, CalaseptPlusCeramir Protect LC | 2016 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Ceramir Bioceramic Implant Cement QuikCapCeramir Crown & Bridge QuikCapCeramir Crown & Bridge QuikMixEtchant Gel | 2017 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | SendoCem MTASendoSeal MTA | 2024 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Big Apical FilesPaste FillerS1 PlusS5 Rotary Files Starter PackS5 SystemSendoline S3 System | 1985 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Barman's WedgesCalasept Paste Needle, CalaseptPlus Flexi-Needle, Calasept Irrigation NeedlePhysics Forceps and Bumper GuardsPrepSure | 2002 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | Supra disc | 2021 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Ceramir CAD/CAM block | 2024 |
| Disk GuardEEJ · Class 1 | — | Maker | Snap-on Discguard | 2021 |
| Articulation PaperEFH · Class 1 | — | Maker | TrollFoil | 2021 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | CHEEK RETRACTORTrollBagTrollByteTrollByte Kimera | 2002 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | ProphyCare ProphyCup | 2002 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | ContacEZ Diamond Dental StripContacEZ kits | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | TRAY CLEANER | 1985 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | DRY-DAMRAINBOW DENTAL RUBBER DAM & PUNCH | 2002 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | ContacEZ Incremental Thickness GaugeIWANSSON MEASURING DEVICE | 1985 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Ceramir ApplicatorCOLOUR CODE RINGSFenderPrepFenderWedgeFixyDapFRACFINDERSpot-itSTIK'N PLACE | 1985 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | RAINBOW RUBBER DAM FRAME | 2002 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | ROTOSTAND | 2002 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | ProphyCare | 2002 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Finger SpreaderNiTi Spreader | 2021 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | K-reamer | 2021 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Finger Plugger | 1985 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | H-fileK-fileS-files-finder | 1985 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Barb Broaches | 2021 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | ANCHORAGE POSTBURN OUT POSTPLASTIC PINS | 1985 |
| Preformed CrownELZ · Class 1 | — | Maker | Ceramir Pediatric CrownCoFormCrown FormsDirecta Polycarbonate CrownsFullForm Crown FormsPolycarbonate Crowns TemporaryStrip Crown Forms | 2002 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Luxator® brandLuxator® sharpening stone | 2002 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Directa StripsFenderMateFenderMatePrimeProxyPal | 2007 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Advance Dry Angle TipsDryDent Sublingual, DryDent Parotid | 2016 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | Rondell | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Directa AB lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Maruchi (2), edelweiss dentistry products gmbh (1), S&C Polymer Silicon- Und Composite Spezialitaten GmbH (1), Doxa Dental AB (1), Js Dental Mfg., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Oct 2024 | K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | edelweiss dentistry products gmbh | EBF Resin Tooth Shade Material |
| 20 Nov 2020 | K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | EJK Calcium Hydroxide Cavity Liner |
| 26 Feb 2018 | K170175 | ENDOSEAL MTA | Maruchi | KIF Root Canal Filling Resin |
| 19 Mar 2012 | K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | Maruchi | KIF Root Canal Filling Resin |
| 28 Dec 2011 | K113040 | CERAMIR CROWN & BRIDGE | Doxa Dental AB | EMA Dental Cement |
| 8 Dec 1989 | K895508 | CALASEPT PASTE | Js Dental Mfg., Inc. | EJK Calcium Hydroxide Cavity Liner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIRECTA ABFDA reg. 8030938 | UPPLANDS VAESBY Stockholm, Sweden | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9004750). 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.