FDA.report

Restorative System

Primary DI
D785RESTORATIVEKIT0
Brand
Restorative System
Company
OCO BIOMEDICAL INC
Model
Restorative Instrumentation System
Catalog number
Restorative Kit
Device 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.
Published
2016-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D785RESTORATIVEKIT0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
094146123
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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D785OTCAP10010 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 10OT CAP 102026-02-04
D785OTCAP404 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 4OT CAP 42026-02-04
D785OTPINK404 PACK OT EQUATOR PINK INSERTSOT PINK 4OT PINK 42026-02-04
D785OTPU202 PACK OT EQUATOR IMPRESSION COPINGOT PU 2OT PU 22026-02-04
D785OTYELLOW404 PACK OT EQUATOR YELLOW INSERTOT YELLOW 4OT YELLOW 42026-02-04
D78589490TSI/ERI Locator AbutmentLocator Abutment 0mm89492025-09-03
D7850330T0Osteotomy Former3.3mm Osteotomy Former0330TN2024-12-03
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D7853610ENGPLS0Two Stage Bone Level ImplantEngage Plus3610 Engage Plus2024-12-03
D7853612ENGAGE0Two Stage Bone Level Dental ImplantEngage3612 ENGAGE2024-12-03
D7853612ENGPLS0Two Stage Bone Level ImplantEngage Plus3612 Engage plus2024-12-03
D7853614ENGAGE0Two Stage Bone Level Dental ImplantEngage3614 ENGAGE2024-12-03
D7853614ENGPLS0Two Stage Bone Level ImplantEngage Plus3614 Engage Plus2024-12-03
D7853616ENGAGE0Two Stage Bone Level Dental Implant Engage3616 ENGAGE2024-12-03
D7853616ENGPLS0Two Stage Bone Level ImplantEngage Plus3616 Engage Plus2024-12-03
D785SURGICALGUIDE0SURGICAL GUIDE3D PRINTED SURGICAL GUIDESURGICAL GUIDE2024-12-03
D7856006ENGPLS0Two Stage Bone Level ImplantEngage Plus6006 Engage Plus2024-09-27
D785293325CBTI0SDI Crown and Bridge Abutments (Ti)2.9/3/3.25MM SDI C&B ABUTMENT2.9/3/3.25 CB (Ti)2024-06-28
D785SDI2225CBTI0SDI Crown and Bridge Abutments (Ti)2.2/2.5MM SDI C&B ABUTMENTSDI 2.2/2.5 CB (Ti)2024-06-28
D785002CAPWOBN0HOUSING CAP WITH O-RING002 CAP W/O-RING (002BN900)002 CAP W/O-RING (002BN900)2024-06-26

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