Drill, Dental, Intraoral
FDA product code DZA · Class I (low risk) · 21 CFR 872.4130 · Dental
13510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Aesculap Instruments Corp. 2
- American Safety Equipment Corp. 1
- Dentsply Intl. 1
- Allomedic 1
- Phillip C. Crawford, D.D.S. 1
- Signature One Products, Inc. 1
- Ivoclar North America, Inc. 1
- The Hygenic Corp. 1
- Implant Corp. of America 1
- Tulsa Dental Products, Ltd. 1
- Del Medical Systems Corp. 1
- W&H Dentalwerk Buermoos GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984508 | Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and…DZA · Traditional | W&H Dentalwerk Buermoos GmbH | 06/25/1999SE |
| K962979 | S-53 Introral Dental SystemDZA · Traditional | Del Medical Systems Corp. | 09/25/1996SE |
| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | Tulsa Dental Products, Ltd. | 01/16/1996SE |
| K914724 | Ada Shank ExtensionDZA · Traditional | Implant Corp. of America | 07/27/1993SE |
| K905418 | Gates Glidden DrillsDZA · Traditional | The Hygenic Corp. | 07/25/1991SE |
| K901097 | Fillock ReamerDZA · Traditional | Ivoclar North America, Inc. | 04/25/1990SE |
| K896149 | Anest-Eze Dental Drill RA#2DZA · Traditional | Signature One Products, Inc. | 01/19/1990SE |
| K884187 | Indentec Drill Ra #1DZA · Traditional | Phillip C. Crawford, D.D.S. | 12/22/1988SE |
| K811113 | Riess-LuhrDZA · Traditional | Allomedic | 06/16/1981SE |
| K801888 | Handpiece, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
| K801887 | Drill, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
| K761275 | Airotos LF HandpieceDZA · Traditional | Dentsply Intl. | 12/23/1976SE |
| K760956 | Surgical Micro DrillDZA · Traditional | American Safety Equipment Corp. | 11/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1861-2025 Class II | Plus Initial Drill, Article Number: 103.170;The referred batch was produced without the laser engraving of 7 mm. | Straumann USA LLC | 04/14/2025Open, Classified |
| Z-3205-2017 Class II | THREAD RETRIEVAL DRILL REF 2224Zimmer Biomet is conducting a medical device field correction for various dental products due to several… | Zimmer Dental Inc | 07/10/2017Terminated |
| Z-1947-2009 | ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455…Some of the packages of ACT3020, drills may actually contain an ACT3220 drill. | Biomet 3i, LLC | 06/29/2009Terminated |