Identity
- Trade Name
- HYGENIC FDA UDI
- Generic Name
- Rubber dam punch FDA UDI
- Device Name
- DENTAL DAM PUNCH FDA UDI
- Model / Reference
- H01261C FDA UDI
- Description
- DENTAL DAM PUNCH FDA UDI
Identifiers
- Catalog Number
- H01261C FDA UDI
- Primary DI / UDI-DI
- D661H01261C0 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Rubber dam punch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rubber dam punch
Hygenic by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam punch.
- Premier Rubber Dam Punch — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Dam Punch 1PK — SMART DENTURE CONVERSIONS, LLC · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Pomee — POMEE CORPORATION · Class I
- Pomee — POMEE CORPORATION · Class I
- American Medicals — AMERICAN MEDICALS · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 81f63221-9769-43bd-a4e3-17d24ffc2f1c 34 fields · synced Jun 9, 2026