Identity
- Trade Name
- DENTCA Try-in FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- DENTCA Try-in - Off-White - 1 kg FDA UDI
- Model / Reference
- DENTCA Denture Base II FDA UDI
- Description
- DENTCA Try-in - Off-White - 1 kg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856551007001 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
DENTCA Try-in by Dentca, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentca, Inc.
Sources (2)
- FDA UDI 7a2a23b5-e677-41ba-8284-d0e4238f5d85 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026