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
D785SURGICALGUIDE0SURGICAL GUIDE3D PRINTED SURGICAL GUIDESURGICAL GUIDE2024-12-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21