Identity
- Trade Name
- Scan Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Scan EUDAMEDARi ExCon Implant System FDA UDI
- Model / Reference
- ARIESAR4009T EUDAMEDARIESAR4009 FDA UDI
- Description
- ARi ExCon Implant System FDA UDI
Identifiers
- Catalog Number
- ARIESAR4009T FDA UDI
- Primary DI / UDI-DI
- 08809931183477 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899234Q7 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment analog, laboratory
Scan Abutment by Megagen Implant Co. Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment analog, laboratory.
- Medentika — Medentika GmbH · Class I
- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- Azure — TERRATS MEDICAL SL. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (2)
- FDA UDI c7a90c1b-6551-4923-bdfc-e61f4b540af1 34 fields · synced Oct 8, 2026
- EUDAMED 8b1dc8fa-8b94-4e38-a2fa-d8fc61cf2d49 61 fields · synced Oct 8, 2026