Identity
- Trade Name
- LEVEL ONE CMF, STERILE FDA UDI
- Generic Name
- Temporary mandibular condyle prosthesis FDA UDI
- Device Name
- SCREW, MAXDRIVE, TLTS, FASTENING, TEMPORARY CONDYLAR IMPLANT, TI-6AL-4V FDA UDI
- Model / Reference
- 50-174-04-75 FDA UDI
- Description
- SCREW, MAXDRIVE, TLTS, FASTENING, TEMPORARY CONDYLAR IMPLANT, TI-6AL-4V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10888118131277 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Temporary mandibular condyle prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary mandibular condyle prosthesis
Level One Cmf, Sterile by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LEVEL ONE CMF, STERILE — KLS-Martin L.P. · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- LEVEL ONE CMF, STERILE — KLS-Martin L.P. · Class II
- LEVEL ONE CMF, STERILE — KLS-Martin L.P. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI 710dd82d-a862-4212-9baf-dc87e3344f53 35 fields · synced Jun 8, 2026