FDA.reportPublic FDA data

Zibone

Primary DI
04710986432660
Brand
Zibone
Company
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Model
Zr-G2316
Device description
Guide Pin
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04710986432660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710986432660047109864326604710986432660

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
658658526
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710986432561ZiboneSC-36102020-03-11
04710986432752ZiboneMe-TRC502021-12-31
04710986432714ZibonePk-H36652020-05-01
04710986432493ZiboneIP-36042021-11-05
04710986431717ZiboneMe-M36402020-05-01
04710986432769ZiboneMe-M36472021-04-27
04710986431298ZiboneCST-B112019-04-12
04710986431243ZiboneCST-B692019-03-25
04710986431250ZiboneCST-B152019-03-25
04710986431267ZiboneCST-B15C2019-03-25
04710986431274ZiboneCST-B632019-03-25
04710986431281ZiboneCST-B652019-03-25
04710986432622ZiboneMe-D48222020-05-01
04710986432646ZiboneMe-A48152020-05-01
04710986432530ZiboneSP-36102020-03-11
04710986432592ZiboneTM-36052020-03-11
04710986432509ZiboneIP-40042020-03-10
04710986430970ZiboneZr-P20172019-03-25
04710986430987ZiboneZr-D23162019-03-25
04710986430994ZiboneZr-D28162019-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290108810646Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810653Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810684Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810691Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810707Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810714Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810721Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810738Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810745Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810752Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810769Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18