FDA.reportPublic FDA data

OneBite™ Facial Axis Recorder

Primary DI
07540172012751
Brand
OneBite™ Facial Axis Recorder
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
052116
Catalog number
052116
Device description
Dental facebow measuring device
Published
2020-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
07540172012751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172012751075401720127517540172012751

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dental device intended for use in denture fabrication to record the relative position of the maxillary arch to the temporomandibular joint (TMJ), or the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding correct placement of artificial teeth into a denture base. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540172009539Frost™ 37% Phosphoric Acid Etch 30ml3453013453012016-09-16
07540172009546Frost™ 37% Phosphoric Acid Etch 5ml3455013455012016-09-16
07540172010795Max Etch 35% Phosphoric Acid Etch 30ml3453023453022016-09-16
07540172010801Max Etch 35% Phosphoric Acid Etch 5ml3455033455032016-09-16
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172002363Green Mouldable Edentulous Trays Size 211884211884212020-10-22
07540172001861D-Fine Double Diamond™ Primary Polisher Refill #091315091315092020-10-22
07540172001953D-Fine Double Diamond™ Final High Shine Refill #091325091325092020-10-22

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
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
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G586E8310330Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
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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
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