Prosthetic devices · 21 CFR 872 Subpart D
Fixture Mount Kit
Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. 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
- 119 makers
- Brands and models
- 138
- 510(k) clearances
- 00 in five years
- FDA name
- Fixture Mount Kit
Companies that list NYE
11 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Megagen Implant Co., Ltd. | South Korea | Maker | Abutment Selection Guide Kit · AI Surgical Kit · Anchor Kit · AnyGuide R2 Surgical Kit · +38 | 30 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | ADVANCED KIT (HAK) · Assist KIT · Bone Compaction KIT · Bone Screw KIT · +66 | 68 | 2026 |
| BIO CONCEPT Co., Ltd | China | Maker | BC Removal Kit · BL Mini Kit · BLT Guided Kit · BLT Mini Kit · +6 | 3 | 2022 |
| 3D Diagnostix inc | United States | Maker | — | 1 | 2020 |
| Zhuhai Meierjing Medical Instrument Co., Ltd. | China | Maker | Dental bone extractor · Dental implant carrier · Dental Implant Wrench · Implant bone cup · +7 | — | — |
| Hans Korea | South Korea | Maker | Hans Korea | — | — |
| FFDM Tivoly | France | Maker | Dental Fixture Mount Kit · Universal Post Remover | — | — |
| Theia Holding SA | Switzerland | Maker | FlexDrive® Prosthetic Kit · FlexDrive® Surgical Kit | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
Official records: FDA product classification for NYE · 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