FDA.reportPublic FDA data

GenTek® Scanbody, External Hex, 4.1mmD

Primary DI
04251881769104
Brand
GenTek® Scanbody, External Hex, 4.1mmD
Company
Zfx GmbH
Model
ZFX05Z-ZB-EX-41
Published
2024-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04251881769104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251881769104042518817691044251881769104

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-342-5454dentalcs@zimvie.com

Regulatory Flags#

DUNS number
340880052
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251881769005GenTek® Scanbody, Certain®, 3.4mmDZFX05Z-ZB-CE-342024-04-11
04251881769029GenTek® Scanbody, Certain®, 4.1mmDZFX05Z-ZB-CE-412024-04-11
04251881769043GenTek® Scanbody, Certain®, 5.0mmDZFX05Z-ZB-CE-502024-04-11
04251881769067GenTek® Scanbody, Certain®, 6.0mmDZFX05Z-ZB-CE-602024-04-11
04251881769081GenTek® Scanbody, External Hex, 3.4mmDZFX05Z-ZB-EX-342024-04-11
04251881769128GenTek® Scanbody, External Hex, 5.0mmDZFX05Z-ZB-EX-502024-04-11
04251881769142GenTek® Scanbody, External Hex, 6.0mmDZFX05Z-ZB-EX-602024-04-11
04251881769166GenTek® Scanbody, Eztetic®, 2.9mmDZFX05Z-ZB-EZ-292024-04-11
04251881769180GenTek® Scanbody, Low Profile, 4.8mmDZFX05Z-ZB-LP-482024-04-11
04251881769203GenTek® Scanbody, Tapered Abutment, 4.5mmDZFX05Z-ZB-TA-452024-04-11
04251881769227GenTek® Scanbody, TSV®/Trabecular Metal®, 3.5mmDZFX05Z-ZB-TSV-352024-04-11
04251881769241GenTek® Scanbody, TSV®/Trabecular Metal®, 4.5mmDZFX05Z-ZB-TSV-452024-04-11
04251881769265GenTek® Scanbody, TSV®/Trabecular Metal®, 5.7mmDZFX05Z-ZB-TSV-572024-04-11
04251881703504GenTek® Hexed Gold-Tite Screw, Certain®ZFX09-ZB-CE-HGTS2024-03-27
04251881703542GenTek® Large Gold-Tite Screw, Certain®ZFX09-ZB-CE-LGTS2024-03-27
04251881703627GenTek® Retaining Screw, Eztetic®ZFX09-ZB-EZ-RS2024-03-27
04251881703702GenTek® Retaining Screw, TSV®/Trabecular Metal®ZFX09-ZB-TSV-RS2024-03-27
04251881703740GenTek® Gold-Tite® Hexalobular Screw, Certain®, EngagingZFX09-ZB-CE-HLGTE2024-03-27
04251881703764GenTek® Gold-Tite® Hexalobular Screw, Certain®, Non-EngagingZFX09-ZB-CE-HLGTN2024-03-27
04251881703863GenTek® Hexalobular Retaining Screw, Eztetic®ZFX09-ZB-EZ-HLRS2024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
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EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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