FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRAUMANN TIBRUSH
K Number: K111724
·
Decision Sep 12, 2011
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
41
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRAUMANN TIBRUSH
- K Number
- K111724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4840
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Straumann USA
- Date Received
- June 20, 2011
- Decision Date
- September 12, 2011
- Product Code
- ELB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELB | Scaler, Rotary | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELB), ordered by most recent decision date.
TN-Brush
FDA 510(k)
FDA Class 2
·Dental
TIGRAN PERIBRUSH
FDA 510(k)
FDA Class 2
·Dental
MINIENDO III
FDA 510(k)
FDA Class 2
·Dental
AIR BURBINE HANDPIECE-DENTAL SCALING
FDA 510(k)
FDA Class 2
·Dental
ROTARY SCALER
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Straumann USA
| K Number | Device Name | ||
|---|---|---|---|
| K151328 | PURE Ceramic Implants | Jan 11, 2016 | Substantially Equivalent |
| K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | Jun 28, 2013 | Substantially Equivalent |
| K130724 | CODIAGNOSTIX IMPLANT PLANNING SOFTWARE | Jun 28, 2013 | Substantially Equivalent |
| K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS | Dec 12, 2012 | Substantially Equivalent |
| K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM | Jun 6, 2012 | Substantially Equivalent |
| K113606 | NNC GOLD ABUTMENT FOR BRIDGES | Jan 27, 2012 | Substantially Equivalent |
| K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT | Jan 13, 2012 | Substantially Equivalent |
| K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS | Dec 28, 2011 | Substantially Equivalent |
| K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM | Nov 16, 2011 | Substantially Equivalent |
| K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | Oct 3, 2011 | Substantially Equivalent |