Identity
- Trade Name
- ArgenIS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- AngBase CAM 3.8 FDA UDI
- Model / Reference
- AngBase CAM 3.8 FDA UDI
- Description
- AngBase CAM 3.8 FDA UDI
Identifiers
- Catalog Number
- 127514 FDA UDI
- Primary DI / UDI-DI
- D818127514 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
ArGenIS is a high-quality, sterile dental implant suprastructure designed for permanent intermediate fixture level attachment between a dental implant and final prosthesis/restoration. This device features [map[is_sterile:false is_sterilization_prior_use:true sterilization_methods:Moist Heat or Steam Sterilization]] and is made of various materials [e.g., titanium (Ti), plastic, gold alloy].
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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
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 debcca8f-4cd2-4f28-b95c-8709ff34e4d3 36 fields · synced Aug 3, 2026