FDA.reportPublic FDA data

OneBite Evolution

Primary DI
00850031761681
Brand
OneBite Evolution
Company
Precision Dental Products LLC
Model
OBEV0106
Catalog number
OBEV0106
Device description
OneBite Evolution Technician Kit - Kavo - Std
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850031761971PreviousGS10
00850031761681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031761971008500317619718500317619710850031761971
00850031761681008500317616818500317616810850031761681

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.

Regulatory Flags#

DUNS number
081523806
Device count
1
DM exempt
true
Premarket exempt
true
Kit
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
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
00850031761223OneBite EvolutionOBEV0033OBEV00332022-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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