Dental Device Guide
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Manufacturer registered with FDA

Osteomed, LLC

Addison, TX, United States. Lists 9 dental device types with FDA across 1 registered establishment, and holds 26 510(k) clearances as applicant.

FDA owner/operator9000613Contract manufacturerContract sterilizerManufacturerSpecification developer1 clearance in five years
Device types listed
9
Brands and models
1
510(k) clearances
261991–2022
Markets registered in
14492 registrations outside the US
Establishments
1United States
1991: 21993: 11996: 21997: 21999: 12002: 32003: 32004: 22005: 12006: 22007: 12008: 12014: 12015: 22017: 12022: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 14 markets

Where regulators' registries name Osteomed, LLC as the manufacturer or the registration holder of a device.

All markets
United States: 9 device types listedCanada: 137 registrationsSouth Korea: 102 registrationsSaudi Arabia: 80 registrationsUnited Kingdom: 55 registrationsTaiwan: 42 registrationsBrazil: 29 registrationsCosta Rica: 22 registrationsAustralia: 9 registrationsChina: 5 registrationsPeru: 5 registrationsColombia: 3 registrationsIsrael: 2 registrationsHong Kong: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerOsteomed, LLC26 clearances1991–2022Below
CanadaHealth CanadaRegistration holderOSTEOMED1371999–2018Pure Global AI
South KoreaMFDSManufacturerOsteoMed L.P.OsteoMed LLC · OsteoMed Corporation · +21021999–2025Pure Global AI
Saudi ArabiaSFDAManufacturerOsteoMed LLCOsteoMed L.L.C.80—Pure Global AI
United KingdomMHRAManufacturerOsteomed LLC55—Pure Global AI
TaiwanTFDAManufacturerOSTEOMED422005–2026Pure Global AI
BrazilANVISAManufacturerOSTEOMED LLC.OSTEOMED L.P. · OSTEOMED292007–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerOSTEOMED22—Pure Global AI
AustraliaTGAManufacturerOsteomedOsteomed LP92006–2020Pure Global AI
ChinaNMPARegistration holder奥特麦德医疗器械有限公司OsteoMedOsteoMed5—Pure Global AI
PeruDIGEMIDManufacturerOSTEOMED52022–2025Pure Global AI
ColombiaINVIMAManufacturerOSTEOMED LPOSTEOMED3—Pure Global AI
IsraelAMARManufacturerOsteoMed2—Pure Global AI
Hong KongMDDManufacturerOsteoMed12014–2014Pure 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 Osteomed, LLC 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—2007
External Mandibular Fixator and/or DistractorMQN · Class 2Maxillofacial plates & screwsMaker—2007
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker—2007
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker—2007
Manual Wire Driver and Bone DrillDZJ · Class 2Surgical drills & motorsMaker—2026
Rotary Bone Cutting HandpieceKMW · Class 2Surgical drills & motorsMaker—2007
Dental Air-Powered HandpieceEFB · Class 1Dental handpiecesMaker—2016
Dental BurEJL · Class 1Dental burs & diamondsMaker
Dental Burs
2015
Temporary Mandibular Condyle ProsthesisNEI · Class 2—Maker—2007

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 Osteomed, LLC as the applicant.

Decided510(k)DeviceDevice type
11 Feb 2022K212570OsteoPlan SystemDZJ Manual Wire Driver and Bone Drill
4 Apr 2017K162544OsteoMed PINNACLE DriverKMW Rotary Bone Cutting Handpiece
21 Sep 2015K151195OsteoMed IMF ScrewDZL Intraosseous Fixation Screw
1 Apr 2015K143338Argulated Locking PlatesJEY Bone Plate
18 Dec 2014K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMJEY Bone Plate
15 May 2008K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEMJEY Bone Plate
2 Mar 2007K063792OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
17 Nov 2006K062851OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDEDMQN External Mandibular Fixator and/or Distractor
7 Apr 2006K051798OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEMDZE Root-Form Endosseous Implant
10 Feb 2005K043434OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
8 Jul 2004K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMNEI Temporary Mandibular Condyle Prosthesis
7 Jan 2004K031936OSTEOMED ORTHODONTIC SCREW SYSTEMDZE Root-Form Endosseous Implant
3 Nov 2003K031708OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
10 Sep 2003K030790OSTEOMED ALVEOLAR DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
9 May 2003K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWSJEY Bone Plate
14 Aug 2002K013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
8 Aug 2002K021618OSA RIGID INTERNAL FIXATION SYSTEMJEY Bone Plate
16 Jan 2002K012486OSTEOMED BIORESORBABLE FIXATION SYSTEMDZL Intraosseous Fixation Screw
16 Jun 1999K990944OSTEOMED INTRAORAL DISTRACTION SYSTEMMQN External Mandibular Fixator and/or Distractor
10 Oct 1997K962774OSTEOMED QUICKFIXDZL Intraosseous Fixation Screw
27 Jun 1997K971692OSTEOPOWER SYSTEM AND ACCESSORIESKMW Rotary Bone Cutting Handpiece
14 Nov 1996K963394OSTEOMED TRAMJEY Bone Plate
25 Oct 1996K961418OSTEOMED MSSDZL Intraosseous Fixation Screw
17 Feb 1993K924138OSTEOMED M3 SYSTEM (SBF SYSTEM)JEY Bone Plate
21 Aug 1991K911936OSTEOMED SBF SYSTEM (SBF)DZL Intraosseous Fixation Screw
10 Jun 1991K911937OSTEOMED IB DRILLEFB Dental Air-Powered Handpiece

Registered establishments

EstablishmentLocationWhat it does
OSTEOMEDFDA reg. 2027754ADDISON, TX, United StatesComplaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9000613). 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.