Identity
- Trade Name
- Angled Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Angled Abutment EUDAMEDARi ExCon Implant System FDA UDI
- Model / Reference
- ARIEAAHN50415T EUDAMEDARIEAAHN50415 FDA UDIARIEAAHN50515 FDA UDI
- Description
- ARi ExCon Implant System FDA UDI
Identifiers
- Catalog Number
- ARIEAAHN50415T FDA UDIARIEAAHN50515T FDA UDI
- Primary DI / UDI-DI
- 08809854029555 EUDAMEDFDA UDI08809854029579 FDA UDI
- Basic UDI-DI
- 880972899873H EUDAMED
- 510(k) Number
- K231967 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Angled Abutment by Megagen Implant Co. Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Cleared under the same submission
K231967 also covers:
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- ARi ExCon Implant — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (3)
- FDA UDI cf49c739-26c2-4fdd-8018-11b5d5afaeaa 35 fields · synced Oct 8, 2026
- FDA UDI 51d0e104-329b-487f-91b8-3e9040a076b9 35 fields · synced May 30, 2026
- EUDAMED f970686a-1d7e-454a-9b98-81ac349d9db3 61 fields · synced Oct 7, 2026