SMARTBURS
FDA 510(k) clearance K080687 · decided 2008-06-20
Clearance details
- K-number
- K080687
- Device name
- SMARTBURS
- Applicant
- S.S. White Burs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-11
- Decision date
- 2008-06-20
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- EJL
- Device class
- 1
- Regulation number
- 872.3240
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lakewood, NJ, 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 |
|---|---|---|
| CERADRILL (K071352) | Gebr. Brasseler GmbH & Co. KG | 2007-06-29 |
| BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (K061383) | B.T.I. Biotechnology Institute, Sl. | 2006-08-03 |
| TRI HAWK BUR, FG BUR (K943273) | Tri Hawk Corp. | 1994-08-01 |
| MONOSTERYL (K926205) | Utensili Super Abrasivi | 1994-02-10 |
| DENTAL OR SURGICAL BUR (K923883) | Stratum Dental Technologies, Inc. | 1993-07-27 |
| SILICONT BUR BLOCK (K921406) | Innovators, Inc. | 1992-04-28 |
| SMART BURS TOTAL CARBIDES (K920243) | Vermont Diamond Instruments | 1992-03-25 |
| TIN COATED DENTAL BURS (K911208) | Surgical Precision Instruments, Corp. | 1991-09-16 |
| SMALL INSTRUMENT STERILIZATION/BUR BOX (K910794) | Brevet, Inc. | 1991-05-23 |
| DENTAL BURS (K882183) | Tri-Stage, Inc. | 1988-06-21 |
| STERILIZED DENTAL BIT PACKAGING (K873698) | Florida Diamond Instruments Corp. | 1987-12-03 |
| CB BUR (K863097) | Beavers Dental, Div. Sybron Canada, Ltd. | 1986-08-26 |
Recalls involving this device
No recalls on record reference this clearance.