FDA.reportPublic FDA data

Facial Plane Relator

Primary DI
00850211006144
Brand
Facial Plane Relator
Company
HO DENTAL COMPANY LLC
Model
FPR-102
Device description
This product can be used with bite registration material.The horizontal alignment bar features an arch with 25 fingers for stabilizing the unit within the registration material. The vertical alignment bar snaps on. Comes in bulk of 100
Published
2023-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850211006144PrimaryGS10
00850211006571Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850211006144008502110061448502110061440850211006144
00850211006571008502110065718502110065710850211006571

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
012676012
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850211006229Dynamic Mixing TipsVacu-Mixer Tip2017-10-10
00850211006021Vaccu-sil VPS Heavy Body 50 Impression MaterialRegular Set2017-10-10
00850211006038Vaccu-sil VPS Heavy Body 50 Impression MaterialFast Set2017-10-10
00850211006045Vaccu-sil VPS Light Body CartridgeFast Set2017-10-10
00850211006052Vaccu-sil VPS Light Body CartridgeRegular Set2017-10-10
00850211006083Harmony Anterior Disposable Dual Arch TrayAnterior2017-10-10
00850211006090Harmony Posterior Disposable Dual Arch TryPosterior2017-10-10
00850211006205Vacu-Mixer Automated VPS Mixing MachineVacu-Mixer2017-10-10
00850211006212Mojo VPS Light Body Impression SyringeEmpty2017-10-10
00850211006236Vaccu-sil VPS Heavy Body 120 Impression MaterialFast Set2017-10-10
00850211006243Vaccu-sil VPS Heavy Body 120 Impression MaterialRegular Set2017-10-10
00850211006250Vaccu-sil Bite RegistrationRegular Set2017-10-10
00850211006267Vaccu-Sil Mojo Complete Light Body SyringeRegular Set2017-10-10
00850211006274Vaccu-Sil Mojo Complete Light Body SyringeFast Set2017-10-10
00850211006311VacuCord Gingival Retraction CordSize 002017-10-11
00850211006328VacCord Gingival Retraction CordSize 02017-10-11
00850211006335VacuCord Gingival Retraction CordSize 12017-10-11
00850211006342VacuCord Gingival Retraction CordSize 22017-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
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