Device class
Class II
Regulation 878.4370
Total clearances
7
2020-12-23 → 2025-06-10
Definition
What is Dental Barriers And Sleeves
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4370
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Yongqing Huaguan Dental Instruments Factory |
1 |
0 |
2024-05-09 |
|
Plasdent Corporation |
1 |
0 |
2020-12-23 |
|
Yueying Medical Instruments (Langfang) Co., Ltd. |
1 |
0 |
2025-05-29 |
|
Premium Plus (Dongguan) Limited
|
1 |
0 |
2022-05-11 |
|
Minitube AB |
1 |
0 |
2021-08-03 |
|
Wellmed Dental Medical Supply Co., Ltd.
|
1 |
0 |
2024-10-18 |
|
Fomed Industries, Inc. |
1 |
0 |
2025-06-10 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 99070 |
CPT
|
— |
Medium
|
Miscellaneous supplies/equipment not otherwise specified for office use |
| D9999 |
CDT
|
— |
Medium
|
Dental barrier/sleeve; CDT code for unspecified orthodontic procedure or barrier; may also use CPT 99070 for supplies |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-06-10 |
K250735 |
Fomed Industries, Inc.
|
Dental Barrier and Sleeves |
| 2025-05-29 |
K250606 |
Yueying Medical Instruments (Langfang) Co., Ltd.
|
Dental Barrier and Sleeves |
| 2024-10-18 |
K242435 |
Wellmed Dental Medical Supply Co., Ltd.
|
Dental Barrier and Sleeves |
| 2024-05-09 |
K233918 |
Yongqing Huaguan Dental Instruments Factory
|
Dental Barrier and Sleeves |
| 2022-05-11 |
K220662 |
Premium Plus (Dongguan) Limited
|
Disposable Barrier Sleeves |
| 2021-08-03 |
K211026 |
Minitube AB
|
Minitube Dentasleeve Protective Barrier Sleeves |
| 2020-12-23 |
K201604 |
Plasdent Corporation
|
Plasdent Disposable Barrier Sleeves and Barrier Film |