Identity
- Trade Name
- ArgenIS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- TiBase CAM 4.3 .3G E FDA UDI
- Model / Reference
- TiBase CAM 4.3 .3G E FDA UDI
- Description
- TiBase CAM 4.3 .3G E FDA UDI
Identifiers
- Catalog Number
- 131397 FDA UDI
- Primary DI / UDI-DI
- D818131397 FDA UDI
- 510(k) Number
- K191986 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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 implant suprastructure, permanent, preformed
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 implant suprastructure, permanent, preformed.
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Cleared under the same submission
K191986 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
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
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 1356e60a-0928-4242-bf19-87e96c562247 36 fields · synced May 30, 2026