Identity
- Trade Name
- Hard Inlay Wax (ivory chunks) FDA UDI
- Generic Name
- Wax dental impression material FDA UDI
- Device Name
- Hard Inlay Wax (ivory chunks) FDA UDI
- Model / Reference
- 5312-1 FDA UDI
- Description
- Hard Inlay Wax (ivory chunks) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10697660004584 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Wax dental impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- Not 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
No
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
Dimensions & Sizes
- Size
- Weight — 1 Pound FDA UDIWeight — 454 Gram FDA UDI
Hard Inlay Wax (ivory chunks) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Oculo-Plastik Inc
Sources (1)
- FDA UDI 925ae1b5-14b2-46f4-8f13-ca7661d57c74 36 fields · synced May 31, 2026