STRAUMANN TIBRUSH
FDA 510(k) clearance K111724 · decided 2011-09-12
Clearance details
- K-number
- K111724
- Device name
- STRAUMANN TIBRUSH
- Applicant
- Straumann USA
- Decision
- Substantially Equivalent
- Date received
- 2011-06-20
- Decision date
- 2011-09-12
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- ELB
- Device class
- 2
- Regulation number
- 872.4840
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, 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 |
|---|---|---|
| TN-Brush (K170596) | Genoss Co., Ltd. | 2017-09-11 |
| TIGRAN PERIBRUSH (K121114) | Tigran Technologies AB | 2012-09-17 |
| MINIENDO III (K003640) | Sybron Dental Specialties, Inc. | 2001-02-22 |
| AIR BURBINE HANDPIECE-DENTAL SCALING (K831037) | Taco Dental, Inc. | 1983-05-09 |
| ROTARY SCALER (K782007) | Star Dental Mfg. Co. | 1979-01-03 |
Recalls involving this device
No recalls on record reference this clearance.