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Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 006-030
Identity
- Trade Name
- Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive EUDAMEDPrime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Bonding Agents EUDAMEDA 5th generation, single component, multi-use adhesive and glue. FDA UDI
- Model / Reference
- 006-030 EUDAMEDFDA UDI
- Description
- A 5th generation, single component, multi-use adhesive and glue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817441022658 EUDAMEDFDA UDI
- Basic UDI-DI
- 081744102TF0257 EUDAMED
- 510(k) Number
- K001108 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dentine bonding agent/set
Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive by Prime Dental Manufacturing — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Dentine bonding agent/set.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081744102TF0257 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 1cdca897-17a9-46f4-b732-d20208c30ed9 61 fields · synced Aug 4, 2026
- FDA UDI 6c6afefc-d17c-4eca-b597-88f85a180bb5 35 fields · synced May 30, 2026