SWISSPLANT DENTAL IMPLANT SYSTEM
FDA 510(k) clearance K081396 · decided 2009-01-14
Clearance details
- K-number
- K081396
- Device name
- SWISSPLANT DENTAL IMPLANT SYSTEM
- Applicant
- Implant Direct, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-19
- Decision date
- 2009-01-14
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Calabasas, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Implant Direct
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 |
|---|---|---|
| SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 recall (Z-1126-2020) | Implant Direct Sybron Manufacturing LLC | 2020-02-10 |
| DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured recall (Z-0396-2016) | Implant Direct Sybron Manufacturing, LLC | 2015-12-08 |