Dental Barriers and Sleeves (AB0006)— 510(k) K261956
Substantially EquivalentANI Co., Ltd.
FDA 510(k) clearance K261956 for Dental Barriers and Sleeves (AB0006), Substantially Equivalent on 2026-09-08. Applicant: ANI Co., Ltd.. Device class: 2.
Summary
ANI Co.'s Dental Barriers and Sleeves (AB0006) are filed under PEM, dental barriers and sleeves. The record doesn't describe the material or what the barriers cover.
Class II, 21 CFR 878.4370. The Dental review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
ANI filed from Suwon-Si, Gyeonggi-Do, South Korea. The decision came 89 calendar days after receipt (June 11 to September 8, 2026).
Clearance details
- Applicant
- ANI Co., Ltd.
- Product code
- Product code PEM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, Gyeonggi-Do, KR
Recent devices under product code PEM
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