Identity
- Trade Name
- ISI C&B PROSTHETIC KIT FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
- Device Name
- 4.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT FDA UDI
- Model / Reference
- 4.0MM ISI C&B PROSTHETIC KIT FDA UDI
- Description
- 4.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT FDA UDI
Identifiers
- Catalog Number
- 4.0 I-CB PK (F) FDA UDI
- Primary DI / UDI-DI
- D78540ICBPKF0 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, single-use 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
Yes
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 analogDental prosthesis/implant abutment screw analog, single-use
Isi C&B Prosthetic Kit by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw analog, single-use.
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- Preat — PREAT Corporation · Class I
- Transfer Impression Coping Guide Pin — Izenimplant Co., Ltd. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
- Pick-up Impression Coping — Izenimplant Co., Ltd. · Class I
- Paltop — Paltop Advanced Dental Solutions, 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 0fe7d47c-6e47-4333-b6ca-e687cc30c3a6 34 fields · synced May 30, 2026