P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
FDA 510(k) clearance K071585 · decided 2007-07-11
Clearance details
- K-number
- K071585
- Device name
- P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
- Applicant
- Straumann USA
- Decision
- Substantially Equivalent
- Date received
- 2007-06-11
- Decision date
- 2007-07-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Straumann USA
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, S recall (Z-1037-2008) | Straumann Usa, Llc | 2008-04-30 |