FDA.reportPublic FDA data

Bone Ridge Chisel(Angle)

Primary DI
08800053007504
Brand
Bone Ridge Chisel(Angle)
Company
DENTIS CO. ,LTD
Model
DBCA15
Device description
Dental Implant Instrument / Bone Ridge Chisel(Angle)
Published
2021-06-02
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053007504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053007504088000530075048800053007504

GMDN Terms#

Term, Definition table
TermDefinition
Chisel/osteotome blade handleA hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694721181
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
08800313230017ChecQPEGDCQP272026-08-26
08800313230024ChecQPEGDCQP382026-08-26
08800313230031ChecQPEGDCQP502026-08-26
08800313230048ChecQPEGDCQP532026-08-26
08800313230055ChecQPEGDCQP542026-08-26
08800313230062ChecQPEGDCQP632026-08-26
08800313237429ChecQPEGDCQP322026-08-26
08800313237436ChecQPEGDCQP572026-08-26
08800313237443ChecQPEGDCQP482026-08-26
08800313237450ChecQPEGDCQP602026-08-26
08800313237467ChecQPEGDCQP012026-08-26
08800313237474ChecQPEGDCQP032026-08-26
08800313237481ChecQPEGDCQP282026-08-26
08800313237498ChecQPEGDCQP492026-08-26
08800313237504ChecQPEGDCQP792026-08-26
08800313235449Guide Anchor PinDGAP142026-08-19
08800313235456Guide Bone AnchorDGBA132026-08-19
08800313235463Guide Bone AnchorDGBA112026-08-19
08800313235470Guide Bone AnchorDGBA092026-08-19
08800313235487Guide Fixture AnchorDGFAN132026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18