FDA.reportPublic FDA data

Complete Implant Surgical Kit

Primary DI
D785COMPLETESURGKIT0
Brand
Complete Implant Surgical Kit
Company
OCO BIOMEDICAL INC
Model
Complete Surgical Kit
Catalog number
Complete Surgical Kit
Device description
Complete Surgical KitThe OCO Biomedical Complete Implant Surgical System is organized with theOCO color-coded system that follows the implant placement procedures in aneasy to follow, step-by-step format. Place SDI, 3.0, ISI, TSI, ERI, Macro™ andEngage™ OCO Biomedical implants.All components are labeled for easy removal and return to the tray afterautoclaving 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
true

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral
DZNInstruments, Dental Hand
EILGauge, Depth, Instrument, Dental
EJLBur, Dental
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
DZNInstruments, Dental HandDental1
EILGauge, Depth, Instrument, DentalDental1
EJLBur, DentalDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D785COMPLETESURGKIT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
094146123
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
D785325SB0SCAN BODYTSI/ERI 3.25MM SCAN BODY3.25 SB2024-06-26
D78540SB0SCAN BODYTSI/ERI 4.0MM SCAN BODY4.0 SB2024-06-26
D78550SB0SCAN BODYTSI/ERI 5.0MM SCAN BODY5.0 SB2024-06-26
D78532530SA0SCAN ADAPTER3.25MM ENGAGE PEEK SCAN ADAPTER32530 SA2024-03-12
D78532530SB0SCAN BODY3.25MM ENGAGE SCAN BODY32530 SB2024-03-12
D7854035SA0SCAN ADAPTER4.0MM ENGAGE PEEK SCAN ADAPTER4035 SA2024-03-12
D7854035SB0SCAN BODY4.0MM ENGAGE SCAN BODY4035 SB2024-03-12
D7855045SA0SCAN ADAPTER5.0MM ENGAGE PEEK SCAN ADAPTER5045 SA2024-03-12
D7855045SB0SCAN BODY5.0MM ENGAGE SCAN BODY5045 SB2024-03-12
D7856057SA0SCAN ADAPTER6.0MM ENGAGE PEEK SCAN ADAPTER6057 SA2024-03-12
D7856057SB0SCAN BODY6.0MM ENGAGE SCAN BODY6057 SB2024-03-12
D7850330T0Osteotomy Former3.3mm Osteotomy Former0330TN2024-12-03
D7853610ENGAGE0Two Stage Bone Level Dental ImplantEngage3610 ENGAGE2024-12-03
D7853610ENGPLS0Two Stage Bone Level ImplantEngage Plus3610 Engage Plus2024-12-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
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00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27