FDA.reportPublic FDA data

Drill Extender

Primary DI
D78500100
Brand
Drill Extender
Company
OCO BIOMEDICAL INC
Model
Drill Extender
Catalog number
0010
Device description
Drill Extender
Published
2024-02-19
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D78500100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395040DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395064DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395088DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395101DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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