Product code DZA
- Device name
- Drill, Dental, Intraoral
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4130
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH | 1999-06-25 |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | 1996-09-25 |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | 1996-01-16 |
| K914724 | ADA SHANK EXTENSION | Implant Corp. of America | 1993-07-27 |
| K905418 | GATES GLIDDEN DRILLS | The Hygenic Corp. | 1991-07-25 |
| K901097 | FILLOCK REAMER | Ivoclar North America, Inc. | 1990-04-25 |
| K896149 | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. | 1990-01-19 |
| K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | 1988-12-22 |
| K811113 | RIESS-LUHR | Allomedic | 1981-06-16 |
| K801887 | DRILL, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K801888 | HANDPIECE, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K761275 | AIROTOS LF HANDPIECE | Dentsply Intl. | 1976-12-23 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | 1976-11-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840456224502 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 08806343926371 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926364 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926357 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926340 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926333 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926326 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08806343926319 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 00840456224564 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224557 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224540 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224533 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224526 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224519 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 00840456224496 | JMU | JMU DENTAL, INC | 2026-07-29 |
| 08806343926302 | Sinus Kit | Shinhung MST Co., Ltd. | 2026-07-29 |
| 08800070248737 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800070248751 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800070248744 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800070248720 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800070248713 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800070248706 | Short Drill | Izenimplant Co., Ltd. | 2026-07-27 |
| 08800076422735 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422742 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422759 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422766 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422773 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422780 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422797 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |
| 08800076422803 | Tapered Drill | Truabutment Korea Co.,Ltd | 2025-12-16 |