SURGICAL MICRO DRILL
FDA 510(k) clearance K760956 · decided 1976-11-19
Clearance details
- K-number
- K760956
- Device name
- SURGICAL MICRO DRILL
- Applicant
- American Safety Equipment Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-01
- Decision date
- 1976-11-19
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- DZA
- Device class
- 1
- Regulation number
- 872.4130
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.