FDA.report

UTS CAD

Primary DI
DVIV6876801
Brand
UTS CAD
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
687680
Catalog number
687680
Device description
UTS CAD
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCRFACEBOW

Product Code Classifications

CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DVIV6876801PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
448015938
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D040022720#2240Q ART/#8645 FACE BOW IN BOXWHIP-MIX CORPORATIONKCR2025-09-11
07615208459579UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
07615208460483UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
06973329326059Reverse Pull Headgear(Face Mask), Middle, RedAstar Orthodontics Inc.KCR2023-12-31
06973329326066Reverse Pull Headgear(Face Mask), Middle, BlueAstar Orthodontics Inc.KCR2023-12-31
06973329326073Reverse Pull Headgear(Face Mask), Middle, YellowAstar Orthodontics Inc.KCR2023-12-31
06973329326080Reverse Pull Headgear(Face Mask), Middle, OrangeAstar Orthodontics Inc.KCR2023-12-31
06973329326097Reverse Pull Headgear(Face Mask), Middle, PurpleAstar Orthodontics Inc.KCR2023-12-31
06973329326103Reverse Pull Headgear(Face Mask), Middle, GreenAstar Orthodontics Inc.KCR2023-12-31
G586E8310210Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310220Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310310Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310320Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310330Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
E1996624511Bite forkCandulor AGKCR2023-11-16
E1996624531Bite fork SetCandulor AGKCR2023-11-16
E1996625131CRS Set 10Candulor AGKCR2023-11-16
D04020002950Unit-Assy SlidematicWHIP-MIX CORPORATIONKCR2023-10-27
D04020011540Unit Assembly 9645 FBWHIP-MIX CORPORATIONKCR2023-10-27
00850211006144Facial Plane RelatorHO DENTAL COMPANY LLCKCR2023-05-17
00842331179730Novo Surgical Inc. NOVO SURGICAL, INC.KCR2022-11-14
E4942186801accessoryAmann Girrbach AGKCR2022-09-08
E4942186901accessoryAmann Girrbach AGKCR2022-09-08
E4942176951accessoryAmann Girrbach AGKCR2022-09-07
E4942186071accessoryAmann Girrbach AGKCR2022-09-07
E4942186351accessoryAmann Girrbach AGKCR2022-09-07
E4942176112accessoryAmann Girrbach AGKCR2022-08-22
E4942176611accessoryAmann Girrbach AGKCR2022-08-22
E4942179285accessoryAmann Girrbach AGKCR2022-08-22
E4942186001ArtexAmann Girrbach AGKCR2022-08-22