Manufacturer registered with FDA
Tecomet
Woburn, MA, United States. Lists 11 dental device types with FDA across 5 registered establishments.
- Device types listed
- 11
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 13215 registrations outside the US
- Establishments
- 5United States
Registered in 13 markets
Where regulators' registries name Tecomet 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 | Tecomet | 11 device types | — | Below |
| Colombia | INVIMA | Manufacturer | TECOMET INCTECOMET, INC · SYMMETRY MEDICAL MANUFACTURING INC. · +2 | 52 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Symmetry Medical Manufacturing Inc | 40 | 2005–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SYMMETRY MEDICAL MANUFACTURINGSymmetry Medical Manufacturing, Inc. · Symmetry Medical Manufacturing · +2 | 40 | 2001–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Symmetry Medical Manufacturing, Inc. | 30 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Tecomet Inc.Symmetry Medical Manufacturing, Inc. · Tecomet, Inc. | 13 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SYMMETRY MEDICAL MANUFACTURING, INC | 12 | 2005–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TECOMETTECOMET INC. · SYMMETRY MEDICAL MANUFACTURING, INC. · +2 | 12 | 2006–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TECOMET INC.SYMMETRY MEDICAL MANUFACTURING · Tecomet Inc. | 7 | 2014–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SYMMETRY MEDICAL MANUFACTURING, INC.SYMMETRY MEDICAL MANUFACTURING INC · Symmetry Medical Manufacturing Inc | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TECOMET INC. | 2 | 2022–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Symmetry Medical Manufacturing, Inc. | 2 | 2022–2022 | Pure Global AI |
| China | NMPA | Registration holder | 赛美特力医药生产有限公司Symmetry Medical Manufacturing, Inc. | 1 | — | 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 Tecomet currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Manual Hip | 2007 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | PFR | 2007 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | PFR | 2007 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | PFR | 2007 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | PFR | 2007 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | PFR | 2007 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | PFR | 2007 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Narrow Cement Removal Gouge, LongTURON, KEELED GLENOID, DRILL GUIDE 2 | 2013 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw system | 2013 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Cranialplasty | 2017 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | ACE Bone Screw Tacking Kit (Tray Only)ACE Implant Dilators (Tray Only)ACE Offset Osteotome (Tray Only)ACE Paralleling Drill Guide (Tray Only)ACE Ridge Expanding Chisel Osteotome (Tray Only)ACE Sinus Lift (Tray Only)ACE Sinus Lift Osteotomes (Tray Only)Genesis Implant System (Tray Only)Prima Implant System (Tray Only)Restore Implant System (Tray Only) 2 moreStage-1 Implant System and Renova Implant System (Tray Only)XP1 Implant System (Tray Only) | 2013 |
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 |
|---|---|---|
| SYMMETRY MEDICAL MANUFACTURING INCFDA reg. 3005061536 | CLAYPOOL, IN, United States | Contract manufacturer, Manufacturer, Specification developer |
| SYMMETRY MEDICAL MANUFACTURING INC.FDA reg. 1828464 | WARSAW, IN, United States | Contract manufacturer, Manufacturer, Specification developer |
| SYMMETRY MEDICAL, INC. - MANCHESTERFDA reg. 1221053 | MANCHESTER, NH, United States | Contract manufacturer |
| TECOMETFDA reg. 1226425 | Woburn, MA, United States | Contract manufacturer |
| TECOMET, INC.FDA reg. 2132732 | KENOSHA, WI, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Symmetry Medical Manufacturing, Inc. · Symmetry Medical, Inc. - Manchester
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1828464, 10031319, 10031318). 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.