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Restorative System

FDA UDI

Class I (US FDA UDI)

by Oco Biomedical

Identity

Trade Name
Restorative System FDA UDI
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Restorative Instrumentation System Everything you need to restore our entire line of two-stage implants A system that contains all instrumentation needed to restore our entire line of two stage dental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeled for easy removal and return to the tray after autoclaving for sterilization. FDA UDI
Model / Reference
Restorative Instrumentation System FDA UDI
Description
Restorative Instrumentation System Everything you need to restore our entire line of two-stage implants A system that contains all instrumentation needed to restore our entire line of two stage dental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeled for easy removal and return to the tray after autoclaving for sterilization. FDA UDI

Identifiers

Catalog Number
Restorative Kit FDA UDI
Primary DI / UDI-DI
D785RESTORATIVEKIT0 FDA UDI
FDA Product Code
EIL FDA UDI
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Restorative System by Oco Biomedical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oco Biomedical

Sources (1)

  • FDA UDI 52702d99-704f-471c-a6ae-d1a9cb0b7b8a 35 fields · synced Jun 8, 2026