Identity
- Trade Name
- I-FIX Abutment Screw FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- I-FIX Abutment Screw / DMS FDA UDI
- Model / Reference
- DMS FDA UDI
- Description
- I-FIX Abutment Screw / DMS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169132048 FDA UDI
- 510(k) Number
- K230203 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
I-FIX Abutment Screw by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K230203 also covers:
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment Screw — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment Screw — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment Screw — DENTIS CO. , LTD
- I-FIX Angled Type Fixture Healing Abutment Screw — DENTIS CO. , LTD
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
- Dentis Co. , Ltd
Sources (1)
- FDA UDI 28cf2d85-c648-42ca-bd42-5b7871ac1558 34 fields · synced May 31, 2026