Identity
- Trade Name
- Implant Prosthetics FDA UDI
- Generic Name
- Dental laboratory mandrel FDA UDI
- Device Name
- NobelBiocare™ Tri-Lobe-compatible NP Digital Analog (25-Pack) FDA UDI
- Model / Reference
- 9000403-25 FDA UDI
- Description
- NobelBiocare™ Tri-Lobe-compatible NP Digital Analog (25-Pack) FDA UDI
Identifiers
- Catalog Number
- 9000403-25 FDA UDI
- Primary DI / UDI-DI
- 00842092134696 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Dental laboratory mandrel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Implant Prosthetics by PREAT Corporation — 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
- PREAT Corporation
Sources (1)
- FDA UDI 80170ce5-04e9-4489-aad0-e658a4f86ffc 36 fields · synced Jun 1, 2026