510(k) clearance
Dental Barriers and Sleeves (AB0006)
- 510(k) number
- K261956
- Applicant
- ANI Co., Ltd.
- Decision date
- Sep 8, 2026
- Date received
- Jun 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PEM
- Device type
- Dental Barriers And Sleeves
- Device class
- Class II
- Regulation
- 21 CFR 878.4370
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Suwon-Si, Gyeonggi-Do, KR