Identity
- Trade Name
- Wax Disc / D-98-10-WD-BL00-SD FDA UDI
- Generic Name
- Wax dental impression material FDA UDI
- Model / Reference
- D-61001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842271163424 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Wax Disc / D-98-10-WD-BL00-SD by Sagemax Bioceramics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sagemax Bioceramics, Inc.
Sources (1)
- FDA UDI 38ef2580-6fb4-49cf-9471-3024d258e768 33 fields · synced Jun 1, 2026