Prosthetic devices · 21 CFR 872 Subpart D
Dental Implant Surgical Tray
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Companies listing it
- 1916 makers
- Brands and models
- 54
- 510(k) clearances
- 00 in five years
- FDA name
- Dental Implant Surgical Tray
Companies that list OFY
19 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Ossvis Co., Ltd. | South Korea | Maker | Lili Guide Kit · Lilivis Guide Full Kit · Sinus & GBR Kit · Surgical Master Kit · +5 | 7 | 2024 |
| B.t.i. Biotechnology | Spain | Maker | — | 14 | 2024 |
| Keystone Dental Inc. | United States | Maker | Genesis Implant System · Prima Dental Implant System · RENOVA Dental Implant System · RESTORE Dental Implant System · +1 | 7 | 2024 |
| Imagine Milling Technologies, LLC | United States | Maker | SIC Drill | 4 | 2026 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | Adin Drill Stop Kits (Regular Long, Regular Short, Wide Long. Wide Short) · Adin Tri Step Drill Stop Kit · CloseFit Metal Surgical Box (Small, Big) · Guided Surgery Accessories Kit - UniFit Implants · +7 | 3 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | OKT Micro Kit 3.75 BL · OKT Micro Kit 3.75 BLT · OKT Micro Kit 3.75 TL · OKT Surgical Kit Mini BLT · +1 | 14 | 2025 |
| SIC invent AG | Switzerland | Maker | — | 5 | 2026 |
| Ditron Dental Ltd | Israel | Maker | Dental Implant Surgical Tray · Surgical Kit full, Mini Surgical Kit, Stainless Steel Surgical Tube, Integral Stopper Kit | 2 | 2024 |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Implant Surgical Tray (Kit) | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Dental orthodontic kit | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Orthodontic kit | — | — |
| Tecomet | United States | Maker | ACE Bone Screw Tacking Kit (Tray Only) · ACE Implant Dilators (Tray Only) · ACE Offset Osteotome (Tray Only) · ACE Paralleling Drill Guide (Tray Only) · +8 | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Dental Implant Surgical Tray CHIRMED | — | — |
| Dental Engineering Laboratories | United States | Maker | TFRK-CS | — | — |
| Symmetry Medical Polyvac SAS | France | Maker | SDS Surgical Tray · Surgical Tray TiLobeMAXX/I-HEXMRT | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Biotech Dental | United States | Manufacturer | Implant Prosthetic Kit · Implant Surgical Kit | 1 | 2024 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
Official records: FDA product classification for OFY · 21 CFR 872.3980.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026