BB Base 3D printing resin for denture base
FDA 510(k) clearance K191591 · decided 2020-08-18
Clearance details
- K-number
- K191591
- Device name
- BB Base 3D printing resin for denture base
- Applicant
- Enlighten Materials Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-14
- Decision date
- 2020-08-18
- Days to decision
- 431 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Enlighten Materials Co.
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.