Identity
- Trade Name
- ELEPHANDENS EUDAMED10TEMP FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- 10TEMP RATAVA DISC 5 LAYERS COLOR BL3 95/25mm FDA UDI
- Model / Reference
- Artificial Teeth EUDAMEDD8A458 EUDAMEDDISC BL3 5 LAYERS 95/25mm FDA UDI
- Description
- 10TEMP RATAVA DISC 5 LAYERS COLOR BL3 95/25mm FDA UDI
Identifiers
- Catalog Number
- RGZ-BL3-25 FDA UDI
- Primary DI / UDI-DI
- 08435288481586 EUDAMEDFDA UDI
- Basic UDI-DI
- 084352884UD-TEETHVS EUDAMED
- 510(k) Number
- K150432 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridge
10temp by Union Dental Sa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge.
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- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
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Cleared under the same submission
K150432 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Union Dental Sa
Sources (2)
- FDA UDI 68ff4a72-00dc-4645-a872-23740d239b77 35 fields · synced Jun 18, 2026
- EUDAMED d124e6bd-f97e-4fde-899c-8b1a11a878f3 61 fields · synced Jun 18, 2026