Identity
- Trade Name
- INNO Submerged Implant System-Impression Coping FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Model / Reference
- 2SIHR001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471723614 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 Submerged Implant System-Impression Coping by Cowellmedi Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- 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 (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 I | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd
Sources (1)
- FDA UDI 337b304b-e238-4f2f-8c47-0b1c430a9455 32 fields · synced May 31, 2026