FDA.reportPublic FDA data

OneBite Evolution

Primary DI
00850031761131
Brand
OneBite Evolution
Company
Precision Dental Products LLC
Model
OBEV0018
Catalog number
OBEV0018
Device description
Articulator Plates Denar® Mk 2
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
00850031761131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031761131008500317611318500317611310850031761131

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
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
D12518N4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4042Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4052Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254334Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254344Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254354Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254364Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254374Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254384Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254394Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254404Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254514Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254524Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254534Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254544Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254554Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254564Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254574Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254584Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254594Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254604Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D125N4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09