Identity
- Trade Name
- INNO Implant System-Analog FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Model / Reference
- 2SACR055 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471724093 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant analog
INNO Implant System-Analog by Cowellmedi Co., Ltd — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd
Sources (2)
- FDA UDI 822aebe2-91a2-47fd-8114-e4bb07f5c8d9 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 25, 2026