Identity
- Trade Name
- I-FIX Angled Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Implant System / I-FIX Angled Abutment D4.0mm X L9.8mm, Angulation 15° FDA UDI
- Model / Reference
- DMAA15 FDA UDI
- Description
- Dental Implant System / I-FIX Angled Abutment D4.0mm X L9.8mm, Angulation 15° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169104328 FDA UDI
- 510(k) Number
- K083586 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
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
Category: Dental implant suprastructure, permanent, preformed
I-FIX Angled Abutment by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- Temporary Abutment — Cybermed Inc. · Class II
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Cleared under the same submission
K083586 also covers:
- I-FIX Abutment Screw — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — DENTIS CO. , LTD
- I-FIX Angled Type Fixture — 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 b70d28a9-bc55-40d9-a36d-083e00bcbca7 34 fields · synced May 30, 2026