Dental Barriers and Sleeves (AB0006)
ANI Co., Ltd. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Suwon-Si, Gyeonggi-Do
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 4f, Bldg. B
- Address 2
- 182, Saneop-Ro 156beon-Gil
- Statement or summary
- Summary
- Product code
- PEM
- Zip code
- 16648
- Applicant
- ANI Co., Ltd.
- Decision date
- 2026-09-08
- Decision code
- SESE
- Country code
- KR
- Device name
- Dental Barriers and Sleeves (AB0006)
- Advisory committee
- SU
- Contact
- Seongcheol Kim
- K number
- K261956
- Date received
- 2026-06-11
- Review advisory committee
- DE
- Postal code
- 16648
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Dental Barriers And Sleeves
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- Registration number
- 3004046477, 1051614, 9612352, 2032574, 3014683120, 2182318, 3024088964, 2428225, 2515379, 2133714, 1941138, 3009496224, 3010656982, 3007046497, 8032009, 3012664306, 3044819802, 3010598169, 3005665377, 3004966444, 3035858919, 3038718579, 3045855232, 2437780, 3011824442, 2424472, 3001468798, 9680887, 3004425647, 2024980, 3015276580, 3017910185, 2183301, 2435946, 3015491448, 2320721, 3006847937, 2029234, 8010638, 8010908 +10 more
- FEI number
- 3004046477, 1051614, 3014683120, 2182318, 3024088964, 2428225, 2515379, 3003706371, 1941138, 3009496224, 3007046497, 3010656982, 3001697252, 3012664306, 3044819802, 3010598169, 3005665377, 3004966444, 3035858919, 3038718579, 3045855232, 3000209941, 3011824442, 3008875470, 3002718942, 3004425647, 3000719964, 3015276580, 3017910185, 2183301, 1000137528, 3004724816, 3008439903, 3015491448, 3002808636, 3006847937, 2511556, 3001746544, 3014345250, 3002088145 +10 more