DZA
13 FDA 510(k) clearances · Product code
56 daysmedian time to decision
233 days90th percentile
13clearances measured
FDA profile
- Official device name
- Drill, Dental, Intraoral
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4130
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2014: 17 · 2015: 9 · 2016: 14 · 2017: 13 · 2018: 14 · 2019: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD (K984508) | W&H Dentalwerk Buermoos GmbH | 1999-06-25 |
| S-53 INTRORAL DENTAL SYSTEM (K962979) | Del Medical Systems Corp. | 1996-09-25 |
| PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (K954790) | Tulsa Dental Products, Ltd. | 1996-01-16 |
| ADA SHANK EXTENSION (K914724) | Implant Corp. of America | 1993-07-27 |
| GATES GLIDDEN DRILLS (K905418) | The Hygenic Corp. | 1991-07-25 |
| FILLOCK REAMER (K901097) | Ivoclar North America, Inc. | 1990-04-25 |
| ANEST-EZE DENTAL DRILL RA#2 (K896149) | Signature One Products, Inc. | 1990-01-19 |
| INDENTEC DRILL RA #1 (K884187) | Phillip C. Crawford, D.D.S. | 1988-12-22 |
| RIESS-LUHR (K811113) | Allomedic | 1981-06-16 |
| HANDPIECE, DENTAL (K801888) | Aesculap Instruments Corp. | 1980-08-20 |
| DRILL, DENTAL (K801887) | Aesculap Instruments Corp. | 1980-08-20 |
| AIROTOS LF HANDPIECE (K761275) | Dentsply Intl. | 1976-12-23 |
| SURGICAL MICRO DRILL (K760956) | American Safety Equipment Corp. | 1976-11-19 |
Track DZA automatically
Every clearance here is in the API, with alerts when new ones post.