Prime-Dent Impression Tray Adhesive
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Prime-Dent Impression Tray Adhesive EUDAMEDPrime Dent Tray Adhesive Blue FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- Tray Adhesive EUDAMEDPrime Dent Tray Adhesive Blue FDA UDI
- Model / Reference
- TF17 EUDAMED017-020 EUDAMEDFDA UDI
- Description
- Prime Dent Tray Adhesive Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817441023433 EUDAMEDFDA UDI
- Basic UDI-DI
- 081744102TF175L EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Dental impression material adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Silicone dental impression material
Prime-Dent Impression Tray Adhesive by Prime Dental Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081744102TF175L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 50616607-c539-46d6-84ca-8af313a627e8 61 fields · synced Jun 19, 2026
- FDA UDI baa8c435-6df0-4969-afa9-356908e98c5b 33 fields · synced May 29, 2026