Identity
- Trade Name
- DENTASTIC UNO FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- SINGLE COMPONENT DENTAL ADHESIVE, LIGHT CURE UNO Kit: 2 x 6 mL bottles Dentastic UNO, 5 mL etch gel, 20 APPLICATOR TIPS, 50 BRUSH TIPS, BRUSH HANDLE FDA UDI
- Model / Reference
- UNO FDA UDI
- Description
- SINGLE COMPONENT DENTAL ADHESIVE, LIGHT CURE UNO Kit: 2 x 6 mL bottles Dentastic UNO, 5 mL etch gel, 20 APPLICATOR TIPS, 50 BRUSH TIPS, BRUSH HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701UNO2 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
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: Dentine adhesive
Dentastic Uno by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Pulpdent Corporation
Sources (1)
- FDA UDI 01b5ea06-56e7-416f-8dd3-e1e6905e7e2b 33 fields · synced Jun 9, 2026