FDA.reportPublic FDA data

Gnathometer M mit UTS Adapter

Primary DI
DIVO530484BN1
Brand
Gnathometer M mit UTS Adapter
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
530484BN
Catalog number
530484BN
Device description
Gnathometer M with UTS Adapter
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
DIVO530484BN1PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
448015938
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208474398Clinical Auxiliary (no MD)7608167608162026-07-14
07615208592634Ivotion Dent7711817711812026-07-09
07615208592689Ivotion Dent7711827711822026-07-09
07615208592696Ivotion Dent7711857711852026-07-09
07615208592702Ivotion Dent7711867711862026-07-09
07615208592719Ivotion Dent7711877711872026-07-09
07615208585728Ivotion Base7712057712052026-07-08
07615208585735Ivotion7712077712072026-07-08
07615208585742Ivotion7712087712082026-07-08
07615208585759Ivotion7712097712092026-07-08
07615208585766Ivotion7712107712102026-07-08
07615208585773Ivotion7712117712112026-07-08
07615208585780Ivotion7712127712122026-07-08
07615208585797Ivotion7712137712132026-07-08
07615208585803Ivotion7712147712142026-07-08
07615208585810Ivotion7712157712152026-07-08
07615208585827Ivotion7712167712162026-07-08
07615208585834Ivotion7712177712172026-07-08
07615208585841Ivotion7712187712182026-07-08
07615208543582IPS e.max Zirconia7644027644022026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208459586Gnathometer M/ Gnathometer CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2024-06-26
DIVO6876791Gnathometer CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26
DVIV530484BN1Gnathometer M mit UTS AdapterIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26
DVIV6876791Gnathometer CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKZO2020-08-26