FDA.reportPublic FDA data

OneBite Evolution

Primary DI
00850031761858
Brand
OneBite Evolution
Company
Precision Dental Products LLC
Model
OBEV0305
Catalog number
OBEV0305
Device description
OneBite Evolution Mounting Table - Sam - LN
Published
2022-04-07
Public version status
New
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
00850031761858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031761858008500317618588500317618580850031761858

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
Lot or batch
true
Manufacturing date on label
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
D1254104Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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
00190707193195Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
00190707193201Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
00190707110789DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110796DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110802DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110819DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110826DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110833DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110840DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110857DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110864DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110871DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110888DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110895DuraLock®Ortho Organizers, Inc.EHY2025-09-25
07615208301304Centric TrayIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHY2025-03-20