Dental Barriers and Sleeves (AB0006)
FDA 510(k) K261956 · ANI Co., Ltd.
510(k) numberK261956
Submission
- Device name
- Dental Barriers and Sleeves (AB0006)
- Applicant
- ANI Co., Ltd.
Suwon-Si, Gyeonggi-Do, KR - Received
- June 11, 2026
- Decision date
- September 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEM – Dental Barriers And Sleeves
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Other 510(k)s with product code PEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250735 | Dental Barrier and SleevesPEM · Traditional | Fomed Industries, Inc. | 06/10/2025SE |
| K250606 | Dental Barrier and SleevesPEM · Traditional | Yueying Medical Instruments (Langfang) Co., Ltd. | 05/29/2025SE |
| K242435 | Dental Barrier and SleevesPEM · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 10/18/2024SE |
| K233918 | Dental Barrier and SleevesPEM · Traditional | Yongqing Huaguan Dental Instruments Factory | 05/09/2024SE |
| K220662 | Disposable Barrier SleevesPEM · Traditional | Premium Plus (Dongguan) Limited | 05/11/2022SE |
| K211026 | Minitube Dentasleeve Protective Barrier SleevesPEM · Traditional | Minitube AB | 08/03/2021SE |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier FilmPEM · Traditional | Plasdent Corporation | 12/23/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | Ivoclar Vivadent, AG | 10/08/2019SE |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier FilmPEM · Traditional | Bh Medical Products Co., Ltd. | 09/10/2019SE |
| K190949 | ScanX Barrier EnvelopesPEM · Traditional | Air Techniques, Inc. | 07/26/2019SE |
More from Air Techniques, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923030 | Ani Biocard HCG TestJHI · Traditional | 09/15/1992SE |
Questions and answers
When was Dental Barriers and Sleeves (AB0006) cleared by the FDA?
Dental Barriers and Sleeves (AB0006) (K261956) received a 510(k) decision of Substantially Equivalent on September 8, 2026, 89 days after the submission was received.
What is the product code of K261956?
The FDA product code is PEM – Dental Barriers And Sleeves, a Class II (moderate risk) device regulated under 21 CFR 878.4370.