Identity
- Trade Name
- TSI/ERI Indexing Impression Coping FDA UDI
- Generic Name
- Dental implant abutment impression cap FDA UDI
- Device Name
- 3.25mm TSI/ERI Indexing Impression Coping 3.25mm Diameter FDA UDI
- Model / Reference
- 3.25mm TSI/ERI Indexing Impression Coping FDA UDI
- Description
- 3.25mm TSI/ERI Indexing Impression Coping 3.25mm Diameter FDA UDI
Identifiers
- Catalog Number
- 3.25 IC FDA UDI
- Primary DI / UDI-DI
- D785325IC0 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment impression cap 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment impression cap
TSI/ERI Indexing Impression Coping by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment impression cap.
- TITAN IMPLANTS, INC. — TITAN IMPLANT INC · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Zibone — COHO BIOMEDICAL TECHNOLOGY CO., LTD. · Class I
- Transfer Abutment — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Aeton Medical — AETON MEDICAL · Class II
- Aeton Medical — AETON MEDICAL · Class II
- i-Clean Excellent Solid Impression Cap — DENTIS CO. , LTD · Class I
- LC Solid Abutment Plastic Impression Coping — Ossvis Co., Ltd. · 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
- Oco Biomedical
Sources (1)
- FDA UDI ed7660fa-b5aa-4485-9fd3-7d108dd61e24 34 fields · synced Jun 6, 2026