Identity
- Trade Name
- HemCon® Dental Dressing PRO, 1in x 3in FDA UDI
- Generic Name
- General oral wound dressing, animal-derived FDA UDI
- Device Name
- The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. FDA UDI
Identifiers
- Catalog Number
- 1052 FDA UDI
- Primary DI / UDI-DI
- 00870053001114 FDA UDI
- 510(k) Number
- K060363 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- GMDN Term
- General oral wound dressing, animal-derived FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: General oral wound dressing, animal-derived
HemCon® Dental Dressing PRO, 1in x 3in by Tricol Biomedical, INC. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General oral wound dressing, animal-derived.
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- RCT Resorbable Collagen Tape — ACE SURGICAL SUPPLY CO., INC. · Class II
- GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U
Cleared under the same submission
K060363 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Tricol Biomedical, INC.
Sources (1)
- FDA UDI f740a971-7324-4004-8168-cacb44acca35 37 fields · synced May 30, 2026