Identity
- Trade Name
- Hygenic FDA UDI
- Generic Name
- Rubber dam clamp FDA UDI
- Device Name
- Fiesta Dam Clamp - #W3 Orange FDA UDI
- Model / Reference
- H02796 FDA UDI
- Description
- Fiesta Dam Clamp - #W3 Orange FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H027960 FDA UDI
- FDA Product Code
- EEF FDA UDI
- GMDN Term
- Rubber dam clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rubber dam clamp
Hygenic by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam clamp.
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCOTT'S SELECT RUBBER DAM CLAMP # 203 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCOTT'S SELECT RUBBER DAM CLAMP # 202 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- BL Clamp — B&L Biotech Co., Ltd. · Class I
- Power Dental U.S.A., Inc. — Power Dental USA, Inc. · Class I
- Power Dental U.S.A., Inc. — Power Dental USA, Inc. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · 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 24397c0e-0bde-453a-8623-ef64f634533c 33 fields · synced Jun 9, 2026