FDA.reportPublic FDA data

UTS 3D/ UTS CAD

Primary DI
07615208459579
Brand
UTS 3D/ UTS CAD
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
687680
Catalog number
687680
Device description
UTS 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
KCRFACEBOW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07615208459579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208459579076152084595797615208459579

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
D040022720#2240Q ART/#8645 FACE BOW IN BOXWHIP-MIX CORPORATIONKCR2025-09-11
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
E1996625211CRS Set 15Candulor AGKCR2023-11-16
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