OpenTex
FDA 510(k) clearance K222549 · decided 2023-05-11
Clearance details
- K-number
- K222549
- Device name
- OpenTex
- Applicant
- Purgo Biologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-23
- Decision date
- 2023-05-11
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- NPK
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Purgo Biologics
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
No recalls on record reference this clearance.