Identity
- Trade Name
- ArgenIS FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- DX 4.5 Ti Blank FDA UDI
- Model / Reference
- DX 4.5 Ti Blank FDA UDI
- Description
- DX 4.5 Ti Blank FDA UDI
Identifiers
- Catalog Number
- 115316 FDA UDI
- Primary DI / UDI-DI
- D818115316 FDA UDI
- 510(k) Number
- K173908 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Dental prosthesis/implant abutment screw
ArgenIS by Argen Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental prosthesis/implant abutment screw.
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Cleared under the same submission
K173908 also covers:
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- Argen — TERRATS MEDICAL SL.
- Azure — TERRATS MEDICAL SL.
- Azure — TERRATS MEDICAL SL.
- Azure — TERRATS MEDICAL SL.
- Azure — TERRATS MEDICAL SL.
- Azure — TERRATS MEDICAL SL.
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
- Argen Corporation, The
Sources (1)
- FDA UDI 4b0f165b-e4c5-4574-960b-f842ebfdc2b2 36 fields · synced May 30, 2026