Identity
- Trade Name
- T-Crystal FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- T-Crystal Thermoplastic Pellets for Dentures by Injection moulding Shade Purple Pink 1kg net jar FDA UDI
- Model / Reference
- Purple Pink FDA UDI
- Description
- T-Crystal Thermoplastic Pellets for Dentures by Injection moulding Shade Purple Pink 1kg net jar FDA UDI
Identifiers
- Catalog Number
- 11007 FDA UDI
- Primary DI / UDI-DI
- 07290110500078 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
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
No
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 appliance fabrication material, thermoplastic
T-Crystal by Perflex — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BioBleach® soft — Dreve Dentamid GmbH · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Perflex
Sources (1)
- FDA UDI 550b38e5-4335-44bd-8d4e-5ab5e4923d8d 35 fields · synced May 30, 2026