FDA.reportPublic FDA data

Zibone

Primary DI
04710986430970
Brand
Zibone
Company
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Model
Zr-P2017
Device description
Zibone Zirconia Point drillDiameter: 2.0 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
04710986430970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710986430970047109864309704710986430970

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
04710986430987ZiboneZr-D23162019-03-25
04710986430994ZiboneZr-D28162019-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290108819120Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819137Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819144Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819151Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819168Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819175Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150147EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150178EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150185EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150192EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150208EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150215EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150222EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150239EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150246EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150253EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150260EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150277EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116155623Diamond BurrNORIS MEDICAL LTDDZA2026-08-17
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29