Dental Device Guide
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Manufacturer registered with FDA

KLS Martin SE & Co. KG

Tuttlingen, Germany. Lists 29 dental device types with FDA across 4 registered establishments, and holds 43 510(k) clearances as applicant.

FDA owner/operator10089006Contract manufacturerSpecification developer6 clearances in five years
Device types listed
29
Brands and models
0
510(k) clearances
431994–2026
Markets registered in
177,536 registrations outside the US
Establishments
4Germany, Malaysia, United States
1994: 31997: 21998: 11999: 32000: 32001: 32002: 12003: 12004: 42005: 12006: 32007: 12008: 12009: 12012: 12014: 12016: 12017: 12018: 32019: 22022: 32024: 22026: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 17 markets

Where regulators' registries name KLS Martin SE & Co. KG as the manufacturer or the registration holder of a device.

All markets
United States: 29 device types listedThailand: 4,019 registrationsSaudi Arabia: 1,305 registrationsCanada: 930 registrationsSerbia: 351 registrationsAustralia: 274 registrationsColombia: 161 registrationsSouth Korea: 129 registrationsTaiwan: 107 registrationsPeru: 100 registrationsBrazil: 76 registrationsEuropean Union: 42 registrationsCosta Rica: 15 registrationsIsrael: 12 registrationsChina: 9 registrationsHong Kong: 5 registrationsJapan: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerKLS Martin SE & Co. KG43 clearances1994–2026Below
ThailandThai FDAManufacturerKLS MARTIN SE & CO. KGKLS Martin SE & Co. KG4,019—Pure Global AI
Saudi ArabiaSFDAManufacturerKLS Martin SE & Co. KG1,305—Pure Global AI
CanadaHealth CanadaRegistration holderKLS MARTIN L.P.KLS MARTIN GMBH + CO. KG9302001–2026Pure Global AI
SerbiaALIMSManufacturerKLS MARTIN SE & Co.KG3512022–2026Pure Global AI
AustraliaTGAManufacturerKLS Martin SE & Co KG2742003–2026Pure Global AI
ColombiaINVIMARegistration holderKLS MARTIN SE & CO. KGKLSMARTIN MALAYSIA SDN. BHD161—Pure Global AI
South KoreaMFDSManufacturerKLS Martin SE & Co. KGKLS Martin SE & Co.KG · KLS Martin Malaysia Sdn. Bhd.1292001–2026Pure Global AI
TaiwanTFDAManufacturerKLS MARTIN SE & CO.KGKLS Martin SE & Co. KG · KLS Martin SE & Co.KG · +21072012–2025Pure Global AI
PeruDIGEMIDManufacturerKLS MARTIN SE & Co. KG1002010–2026Pure Global AI
BrazilANVISAManufacturerKLS MARTIN SE & CO. KG762009–2026Pure Global AI
European UnionEUDAMEDManufacturerKLS Martin SE & Co. KG42—Pure Global AI
Costa RicaMinisterio de SaludManufacturerKLS Martin SE & Co. KGKLS MARTIN L.P.15—Pure Global AI
IsraelAMARManufacturerKLS Martin SE & Co. KGKLS Martin12—Pure Global AI
ChinaNMPARegistration holder玛丁兄弟有限两合公司KLS Martin SE&Co.KG玛丁兄弟有限两合公司 KLS Martin SE&Co.KG · 玛丁兄弟有限两合公司KLS Martin SE & Co.KG · +19—Pure Global AI
Hong KongMDDManufacturerKLS Martin SE & Co. KGKLS Martin SE & CO. KG52024–2026Pure Global AI
JapanPMDARegistration holderＫＬＳ　Ｍａｒｔｉｎ　ＳＥ　＆　Ｃｏ．　ＫＧ12011–2011Pure 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 KLS Martin SE & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Bone PlateJEY · Class 2Maxillofacial plates & screwsMaker—2023
External Mandibular Fixator and/or DistractorMQN · Class 2Maxillofacial plates & screwsMaker—2023
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker—2023
Manual Wire Driver and Bone DrillDZJ · Class 2Surgical drills & motorsMaker—2023
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2023
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—2023
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2023
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2023
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2023
Operative PliersEJY · Class 1Dental hand instrumentsMaker—2023
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—2023
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2023
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker—2023
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2023
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker—2023
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—2023
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—2023
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker—2023
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker—2023
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2023
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—2023
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—2023
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2023
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—2023
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—2023
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker—2023
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker—2023
Subperiosteal ImplantELE · Class 2—Maker—2023
Temporary Mandibular Condyle ProsthesisNEI · Class 2—Maker—2023

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

510(k) clearances

Clearances on which FDA names KLS Martin SE & Co. KG as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
17 Aug 2026K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsJEY Bone Plate
17 Sep 2024K233721KLS Martin Drill-Free MMF ScrewDZL Intraosseous Fixation Screw
16 Aug 2024K241314KLS Martin Oral-Max Implants MR Conditional (bundled)JEY Bone Plate
11 Aug 2022K220050KLS Martin IPS DistractionMQN External Mandibular Fixator and/or Distractor
18 Jul 2022K210731KLS Martin Individual Patient SolutionsJEY Bone Plate
8 Jul 2022K210228KLS Martin IPS PreprostheticELE Subperiosteal Implant
22 Nov 2019K191028KLS Martin Individual Patient SolutionsJEY Bone Plate
11 Mar 2019K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ Manual Wire Driver and Bone Drill
13 Sep 2018K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ Manual Wire Driver and Bone Drill
13 Aug 2018K180962KLS Martin Individual Patient SolutionsJEY Bone Plate
23 Feb 2018K173320KLS Martin L1 MMF SystemJEY Bone Plate
21 Nov 2017K163579KLS Martin Individual Patient SolutionsJEY Bone Plate
1 Dec 2016K161470Internal Distraction - SterileMQN External Mandibular Fixator and/or Distractor
15 May 2014K133304RXG DISTRACTION SYSTEMJEY Bone Plate
23 Mar 2012K112064RESORB X-GJEY Bone Plate
31 Mar 2009K083432DRILL FREE MMF SCREWDZL Intraosseous Fixation Screw
21 Jul 2008K080862SONICWELD RX (RESORB-X)JEY Bone Plate
20 Dec 2007K072764KLS MARTIN XTERNAL FIXATORMQN External Mandibular Fixator and/or Distractor
21 Sep 2006K061507SONICWELD RX ENDOBROW FIXATIONJEY Bone Plate
30 Jun 2006K061271ERCH ARCH BAR, MODEL 38-690-00DYX Intraoral Wire Lock and Ligature
18 Apr 2006K060177KLS MARTIN RIGID FIXATION - STERILEJEY Bone Plate
22 Aug 2005K051236RESORB-X SFJEY Bone Plate
18 Oct 2004K042573KLS MARTIN DRILL-FREE MMF SCREWDZL Intraosseous Fixation Screw
28 May 2004K040891KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)DZE Root-Form Endosseous Implant
27 Feb 2004K034027KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
15 Jan 2004K033483KLS-MARTIN ORTHO ANCHORAGE SYSTEMDZE Root-Form Endosseous Implant
29 Oct 2003K032442KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM IIMQN External Mandibular Fixator and/or Distractor
20 Mar 2002K011590RESORB-X RESORBABLE PLATING SYSTEMJEY Bone Plate
27 Jul 2001K990667KLS-MARTIN TEMPORARY CONDYLAR IMPLANTNEI Temporary Mandibular Condyle Prosthesis
29 Jun 2001K010139ZURICH DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
23 Jan 2001K003883MOLINA ORBITAL MALAR DISTRACTORJEY Bone Plate
10 Oct 2000K002152TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTIONMQN External Mandibular Fixator and/or Distractor
24 Jul 2000K000580ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15MQN External Mandibular Fixator and/or Distractor
15 Feb 2000K994154MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIESJEY Bone Plate
21 Dec 1999K980760KLS-MARTIN MMF SCREWDZL Intraosseous Fixation Screw
18 Aug 1999K991875K-L-W INTRAORAL DISTRACTORMQN External Mandibular Fixator and/or Distractor
26 Jan 1999K983809KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTORMQN External Mandibular Fixator and/or Distractor
30 Nov 1998K983515KLS INTRAORAL VERTICAL DISTRACTORMQN External Mandibular Fixator and/or Distractor
20 Nov 1997K973275KLS-MARTIN INTRAORAL DISTRACTORMQN External Mandibular Fixator and/or Distractor
24 Jun 1997K972047KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICEMQN External Mandibular Fixator and/or Distractor
18 Oct 1994K944565KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)JEY Bone Plate
18 Oct 1994K944561MICRO OSTEOSYNTHESIS SYSTEM (1.0)JEY Bone Plate
18 Oct 1994K944560MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYSTJEY Bone Plate

Some of these clearances are listed with FDA today by another company: Avalign Technologies (1), Integra LifeSciences Corporation (1).

Also lists devices cleared under other names

KLS Martin SE & Co. KG 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: Patton, Boggs & Blow (2).

Decided510(k)DeviceApplicantDevice type
4 Oct 1994K943347KLS MINI OSTEOSYNTHESIS SYSTEMPatton, Boggs & BlowJEY Bone Plate
4 Oct 1994K943348KLS CHIN PLATE SYSTEMPatton, Boggs & BlowJEY Bone Plate

Registered establishments

EstablishmentLocationWhat it does
KLS Martin Malaysia Sdn. Bhd.FDA reg. 3014201171Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer
KLS Martin SE & Co. KGFDA reg. 9610905Muhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer
KLS MARTIN SE & CO. KGFDA reg. 3036795921Fridingen Baden-Wurttemberg, GermanyContract manufacturer
KLS-Martin L.P.FDA reg. 1057946Jacksonville, FL, United StatesSpecification developer

Other names on FDA records

KLS Martin · KLS Martin Malaysia Sdn. Bhd.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10089006). 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.