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
07615208476804Tetric plus Fill762371WW762371WW2026-07-29
07615208476811Tetric plus Fill762372WW762372WW2026-07-29
07615208476828Tetric plus Fill762373WW762373WW2026-07-29
07615208476835Tetric plus Fill762374WW762374WW2026-07-29
07615208476842Tetric plus Fill762375WW762375WW2026-07-29
07615208477658Tetric plus Fill762386WW762386WW2026-07-29
07615208477665Tetric plus Fill762387WW762387WW2026-07-29
07615208477672Tetric plus Fill762388WW762388WW2026-07-29
07615208477689Tetric plus Fill762389WW762389WW2026-07-29
07615208477696Tetric plus Fill762390WW762390WW2026-07-29
07615208477702Tetric plus Flow762391WW762391WW2026-07-29
07615208477719Tetric plus Flow762392WW762392WW2026-07-29
07615208477726Tetric plus Flow762393WW762393WW2026-07-29
07615208477733Tetric plus Flow762394WW762394WW2026-07-29
07615208477740Tetric plus Flow762395WW762395WW2026-07-29
07615208477757Tetric plus Flow762396WW762396WW2026-07-29
07615208477764Tetric plus Flow762397WW762397WW2026-07-29
07615208477771Tetric plus Flow762398WW762398WW2026-07-29
07615208477788Tetric plus Flow762399WW762399WW2026-07-29
07615208570830Adhese 2 100768338WW768338WW2026-07-22

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