Device class
Class II
Regulation 872.3930
Total clearances
5
2021-01-23 → 2023-12-08
Definition
What is Barrier, Synthetic, Intraoral
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
Classification details
Regulation number
872.3930
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
B&Medi Co., Ltd. |
1 |
0 |
2022-08-18 |
|
Osteogenics Biomedical, Inc. |
1 |
0 |
2021-01-23 |
|
Criteria Industria E Comercio DE Produtos Medicinais |
1 |
0 |
2023-12-08 |
|
Purgo Biologics, Inc.
|
1 |
0 |
2023-05-11 |
|
Cowellmedi Co., Ltd.
|
1 |
0 |
2023-02-24 |
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 |
| 21299 |
CPT
|
— |
Medium
|
Unlisted craniofacial and maxillofacial procedure; synthetic barrier placement for guided tissue regeneration |
| D4276 |
CPT
|
— |
Medium
|
Dental-specific code for guided tissue regeneration/bone regeneration procedures with barriers |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-12-08 |
K221851 |
Criteria Industria E Comercio DE Produtos Medicinais
|
Lumina-PTFE Titanium |
| 2023-05-11 |
K222549 |
Purgo Biologics, Inc.
|
OpenTex |
| 2023-02-24 |
K211554 |
Cowellmedi Co., Ltd.
|
InnoGenic Non-resorbable Membrane |
| 2022-08-18 |
K210797 |
B&Medi Co., Ltd.
|
Bio-MEM Ti Reinforced Membrane |
| 2021-01-23 |
K201187 |
Osteogenics Biomedical, Inc.
|
Cytoplast Titanium-Reinforced PTFE Membranes |