Identity
- Trade Name
- THE Cover EUDAMEDFDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- THE Cover EUDAMEDRepair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone. FDA UDI
- Model / Reference
- BP3-1520 EUDAMEDFDA UDI
- Description
- Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039003742 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800039003742 EUDAMED
- 510(k) Number
- K230091 FDA UDI
- FDA Product Code
- NPL FDA UDI
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
- GMDN Term
- Collagen dental regeneration membrane FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
THE Cover by PURGO BIOLOGICS Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230091 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08800039003742 | Class III | Active |
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Manufacturer
- Manufacturer
- Purgo Biologics Inc.
- EUDAMED SRN
- KR-MF-000006105
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 2ff5faa7-6a16-4d43-8a30-f0bbc446e02d 61 fields · synced Jul 19, 2026
- FDA UDI 138fde4a-85e7-4f98-a2df-7b8ab3b3cea0 34 fields · synced May 30, 2026
- FDA 510(k) K230091 1 fields · synced May 18, 2026