Prosthetic devices · 21 CFR 872 Subpart D
Non-Irrigation Endosseous Dental Implant Drill Bits
The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.
- Companies listing it
- 2014 makers
- Brands and models
- 62
- 510(k) clearances
- 00 in five years
- FDA name
- Non-Irrigation Endosseous Dental Implant Drill Bits
Companies that list QRQ
20 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Nobel Biocare Services AG | Switzerland | Maker | Clinical Screw Multi-unit Abutment N1 Trioval Conical Connection · Clinical Screw N1 Base · Clinical Screw N1 Trioval Conical Connection · Guided Pilot Drill N1 · +12 | 94 | 2026 |
| Paragon Implant Mfg., LLC | United States | Maker | Crestal Drill · Hex Drill · Linderman Drill · Starter Drill · +1 | 4 | 2026 |
| DSI Dental Solutions Ltd | Israel | Maker | DSI Dental Implant Drills | 2 | 2025 |
| Mozograu S.A. | Spain | Maker | Fidelis Crestal Drill · TC Fidelis 3,2x10 drill · TC Fidelis 3,2x11 drill · TC Fidelis 3,2x13 drill · +13 | 1 | 2024 |
| Bioline Dental Implant Systems Ltd | Israel | Maker | Cortical Drill · Countersink Drill · Drill Extension · Guided Surgery Drill · +4 | 1 | 2025 |
| MK Meditech | South Korea | Maker | MK Drill Bit | 1 | 2021 |
| Surcam Medical Devices and Developments Ltd | Israel | Maker | Surcam dental implant drills | 1 | 2025 |
| Bicon, LLC | United States | Maker | Reamers · Spade Drills · Surgical Kits · Tissue Punches | 18 | 2015 |
| Comfort Surgical Instruments | Pakistan | Maker | dental implant drills non irrigation | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Micro Precision Swiss, LLC | United States | Maker | Abutment Screw Retrieval Instrument · Implant Retrieval Instrument | — | — |
| DMITechnology LLC | United States | Maker | DMI dental implant drill bits | — | — |
| Xiamen Xiang Ji Precision Machinery Technology Co., Ltd | China | Maker | Implant Pro · Pro Implant | — | — |
| Stomatotech | Canada | Maker | Crown Down Drilling Kit | — | — |
| Quickdent Devices Private Limited | India | Repacker / relabeler | — | 1 | 2024 |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| TBS Dental | United States | Repacker / relabeler | — | — | — |
| Global Dental Transfer Ltd | Israel | Repacker / relabeler | — | — | — |
| Osseo Max Inc | United States | Repacker / relabeler | Osseo Max Dental Implant Drills | — | — |
| AMG Dental Ltd | Israel | Repacker / relabeler | — | — | — |
Official records: FDA product classification for QRQ · 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