FDA.reportPublic FDA data

Gnathometer M/ Gnathometer CAD

Primary DI
07615208459586
Brand
Gnathometer M/ Gnathometer CAD
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
687679
Catalog number
687679
Device description
Gnathometer CAD (ID)
Published
2024-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZOInk, arch tracing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZOInk, Arch TracingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07615208459586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208459586076152084595867615208459586

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
448015938
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208592580IPS e.max Ceram Art7728287728282026-05-04
07615208592597IPS e.max Ceram Art7728297728292026-05-04
07615208482775ProBase Hot / ProBase Cold7641287641282026-04-30
07615208291643OptraGloss742102WW742102WW2026-04-23
07615208295917Variolink Esthetic Try-In666115WW666115WW2026-04-20
07615208482706Variolink Esthetic Try-In762063WW762063WW2026-04-20
07615208539189IPS e.max Zirconia7642737642732026-03-26
07615208539677IPS e.max Zirconia7642817642812026-03-26
07615208539684IPS e.max Zirconia7642937642932026-03-26
07615208539691IPS e.max Zirconia7643017643012026-03-26
07615208539707IPS e.max Zirconia7643137643132026-03-26
07615208539714IPS e.max Zirconia7643217643212026-03-26
07615208539721IPS e.max Zirconia7643337643332026-03-26
07615208539738IPS e.max Zirconia7643417643412026-03-26
07615208539745IPS e.max Zirconia7643537643532026-03-26
07615208540055IPS e.max Zirconia7643617643612026-03-26
07615208540062IPS e.max Zirconia7643737643732026-03-26
07615208540079IPS e.max Zirconia7643817643812026-03-26
07615208540086IPS e.max Zirconia7643937643932026-03-26
07615208542301IPS e.max Zirconia7642747642742026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
DIVO530484BN1Gnathometer M mit UTS AdapterIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26
DIVO6876791Gnathometer CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26
DVIV530484BN1Gnathometer M mit UTS AdapterIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26
DVIV6876791Gnathometer CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26