Identity
- Trade Name
- Hygenic FDA UDI
- Generic Name
- Dental base plate FDA UDI
- Device Name
- Impression Wax - 1/2 lb FDA UDI
- Model / Reference
- H00832 FDA UDI
- Description
- Impression Wax - 1/2 lb FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H008320 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Dental base plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental base plate
Hygenic by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental base plate.
- PARAFFIN WAX — YAMAHACHI DENTAL MFG., CO. · Class I
- Profibase — VOCO GmbH · Class I
- DENTAL WAX — Changshu Shangchi Dental Materials Co., Ltd. · Class I
- Nobilium — CMP INDUSTRIES LLC · Class I
- PROVISA — BENCO DENTAL SUPPLY CO. · Class I
- Dentorium — Wright Health Group , Ltd. · Class I
- LIGHT RESIN PLATE — YAMAHACHI DENTAL MFG., CO. · Class I
- Wrights — Wright Health Group , Ltd. · 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 38e16b76-2263-4bcc-b89c-9dbc8bb30362 34 fields · synced Jun 9, 2026