Obtura III Max Thermal Protectors, 4 pack
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Obtura III Max Thermal Protectors, 4 pack EUDAMEDObtura Spartan FDA UDI
- Generic Name
- Endodontic plugger FDA UDI
- Device Name
- Obtura III Max Thermal Protectors, 4 pack EUDAMEDFDA UDI
- Model / Reference
- 823-815 EUDAMEDFDA UDI
- Description
- Obtura III Max Thermal Protectors, 4 pack FDA UDI
Identifiers
- Catalog Number
- 823-815 FDA UDI
- Primary DI / UDI-DI
- 10843471100438 EUDAMED00843471100431 FDA UDI
- Basic UDI-DI
- B-10843471100438 EUDAMED
- 510(k) Number
- K042828 FDA UDI
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic plugger FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
Obtura III Max Thermal Protectors, 4 pack by Young Innovations, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10843471100438 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED c72ee01e-d459-4cfd-8fce-a16a4f909d4f 61 fields · synced Jul 27, 2026
- FDA UDI e1d9be60-b669-4c1c-bdf6-72ab0a415cc2 36 fields · synced May 25, 2026