Device class
Class II
Regulation 872.3930
Total clearances
17
2020-10-02 → 2025-12-12
Definition
What is Barrier, Animal Source, Intraoral
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Classification details
Regulation number
872.3930
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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; animal-source barrier placement for guided tissue regeneration |
| D4276 |
CPT
|
— |
Medium
|
Guided tissue regeneration/bone regeneration with animal-source barrier material |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-12 |
K242817 |
Botiss Biomaterials GmbH
|
Jason membrane |
| 2025-12-05 |
K250512 |
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
|
Augmented Gingival Matrix |
| 2025-11-25 |
K252253 |
Geistlich Pharma AG
|
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® |
| 2025-08-14 |
K251062 |
Geistlich Pharma AG
|
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack |
| 2025-04-15 |
K250833 |
Geistlich Pharma AG
|
SwissMembrane X; SwissMembrane X Socket |
| 2024-05-01 |
K233203 |
Collagen Matrix, Inc.
|
Soft Tissue Augmentation Resorbable Matrix |
| 2024-02-16 |
K231513 |
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
|
Oral Matrix |
| 2024-01-23 |
K231305 |
Aroa Biosurgery , Ltd.
|
Endoform Dental Membrane |
| 2023-10-06 |
K230091 |
Purgo Biologics, Inc.
|
THE Cover |
| 2023-08-17 |
K223912 |
Sigmagraft, Inc.
|
InterCollagen® Guide |
| 2022-09-30 |
K213904 |
Kerecis
|
Kerecis Oral |
| 2022-07-18 |
K212509 |
Datum Dental, Ltd.
|
OSSIX Breeze |
| 2022-04-05 |
K212463 |
Geistlich Pharma AG
|
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack |
| 2021-03-03 |
K210280 |
Geistlich Pharma AG
|
Geistlich Mucograft®, Geistlich Mucograft® Seal |
| 2021-01-11 |
K201241 |
Orthocell, Ltd.
|
Striate+ |
| 2020-11-13 |
K192612 |
Kerecis Limited
|
Kerecis Gingiva Graft |
| 2020-10-02 |
K200623 |
Sk Bioland Co., Ltd.
|
OssGuide |