SMARTbase Abutment System
FDA 510(k) clearance K223535 · decided 2023-06-20
Clearance details
- K-number
- K223535
- Device name
- SMARTbase Abutment System
- Applicant
- Implant Direct Sybron Manufacturing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-11-23
- Decision date
- 2023-06-20
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Thousand Oaks, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Implant Direct Sybron Manufacturing
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 |
|---|---|---|
| LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-8 recall (Z-2037-2023) | Implant Direct Sybron Manufacturing LLC | 2023-06-29 |