Identity
- Trade Name
- Obtura Spartan FDA UDI
- Generic Name
- Endodontic plugger FDA UDI
- Device Name
- Multi Tool Obtura III @ Max FDA UDI
- Model / Reference
- 823-813 FDA UDI
- Description
- Multi Tool Obtura III @ Max FDA UDI
Identifiers
- Catalog Number
- 823-813 FDA UDI
- Primary DI / UDI-DI
- 00843471152287 FDA UDI
- 510(k) Number
- K042828 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic plugger FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Endodontic plugger
Obtura Spartan by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic plugger.
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- American Eagle Instruments — American Eagle Instruments · Class I
Cleared under the same submission
K042828 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 7abb70df-91bc-44e5-8133-a4a48c6f2dd6 36 fields · synced May 30, 2026