CERADRILL
FDA 510(k) clearance K071352 · decided 2007-06-29
Clearance details
- K-number
- K071352
- Device name
- CERADRILL
- Applicant
- Gebr. Brasseler GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-05-15
- Decision date
- 2007-06-29
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- EJL
- Device class
- 1
- Regulation number
- 872.3240
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lemgo, DE
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gebr. Brasseler GmbH & Co. KG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTBURS (K080687) | S.S. White Burs, Inc. | 2008-06-20 |
| 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.