FDA.reportPublic FDA data

OneBite Evolution

Primary DI
00850031761285
Brand
OneBite Evolution
Company
Precision Dental Products LLC
Model
OBEV0039
Catalog number
OBEV0039
Device description
Articulator Plate and Slider Denar MK2
Published
2022-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850031761285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031761285008500317612858500317612850850031761285

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

Contacts#

Phone, Email table
PhoneEmail
1-866-668-2483admin@onebite.com

Regulatory Flags#

DUNS number
081523806
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031761582OneBite EvolutionOBEV0104OBEV01042026-05-19
00850031761599OneBite EvolutionOBEV0102OBEV01022026-05-19
00850031761612OneBite EvolutionOBEV0101OBEV01012026-05-19
00850031761674OneBite EvolutionOBEV0105OBEV01052026-05-19
00850031761681OneBite EvolutionOBEV0106OBEV01062026-05-19
00850031761698OneBite EvolutionOBEV0107OBEV01072026-05-19
00850087286138OneBite EvolutionOBEV0413OBEV04132026-05-19
00850087286145OneBite EvolutionOBEV0414OBEV04142026-05-19
00850087286152OneBite EvolutionOBEV0415OBEV04152026-05-19
00850087286169OneBite EvolutionOBEV04162026-05-19
00850087286176OneBite EvolutionOBEV0417OBEV04172026-05-19
00850087286183OneBite EvolutionOBEV0418OBEV04182026-05-19
00850087286190OneBite EvolutionOBEV0419OBEV04192026-05-19
00850031761117OneBite EvolutionOBEV0015OBEV00152022-04-07
00850031761001OneBite EvolutionOBEV0022OBEV00222022-04-07
00850031761018OneBite EvolutionOBEV0021OBEV00212022-04-07
00850031761131OneBite EvolutionOBEV0018OBEV00182022-04-07
00850031761179OneBite EvolutionOBEV0005OBEV00052022-04-07
00850031761186OneBite EvolutionOBEV0023OBEV00232022-04-07
00850031761193OneBite EvolutionOBEV0024OBEV00242022-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254124Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
08961104622654Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
08906139322087Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
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