FDA.reportPublic FDA data

Zibone

Primary DI
04710986430994
Brand
Zibone
Company
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Model
Zr-D2816
Device description
Zibone Zirconia Twist drillDiameter: 28 mm
Published
2019-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04710986430994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710986430994047109864309944710986430994

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
04710986432660ZiboneZr-G23162020-05-01
04710986432530ZiboneSP-36102020-03-11
04710986432592ZiboneTM-36052020-03-11
04710986432509ZiboneIP-40042020-03-10
04710986430970ZiboneZr-P20172019-03-25
04710986430987ZiboneZr-D23162019-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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