Identity
- Trade Name
- Obtura III Max System EUDAMEDObtura Spartan FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Obtura III Max System EUDAMEDObtura III Max Heated Gutta Percha System FDA UDI
- Model / Reference
- 823-800 EUDAMEDFDA UDI
- Description
- Obtura III Max Heated Gutta Percha System FDA UDI
Identifiers
- Catalog Number
- 823-800 FDA UDI
- Primary DI / UDI-DI
- 10843471100407 EUDAMED00840326418376 FDA UDI
- Basic UDI-DI
- B-10843471100407 EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
Obtura III Max System 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-10843471100407 | 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 f733c6e2-0d99-4023-ba03-2b5638d1af9f 61 fields · synced Jul 17, 2026
- FDA UDI 087b9e1f-a755-4389-986a-9d191981b3c3 35 fields · synced May 29, 2026