FDA.reportPublic FDA data

ORAPRO

Primary DI
10817713022970
Brand
ORAPRO
Company
ORTHOQUEST, INC.
Model
J815
Catalog number
J815
Device description
ORAPRO G2 7ML LC BONDING RESIN
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935625000ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEWallace A. Erickson & Co.1994-08-10DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817713022970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081771302297010817713022970

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192699952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817713020105ORAPROETCHINKIT2016-09-20
10817713022901Easy Etch960-062017-03-07
10817713022918EASY ETCH960-04J04942017-03-07
10817713022925EASY ETCH960-012017-03-07
00817713020146ORAPRO960-062016-09-20
10817713022345ORTHOQUESTL01712018-08-17
10817713022451ORTHOQUESTL02082018-08-17
10817713022246ORTHOQUESTL01092018-08-17
10817713022253ORTHOQUESTL01102018-08-17
10817713022628ORTHOQUESTL02402018-08-17
10817713021836ACCENTA0668H2018-08-17
10817713022444ORTHOQUESTL02072018-08-17
10817713020211Accent A01502016-09-22
10817713020228AccentA01512016-09-22
10817713020235ACCENTA01522016-09-22
10817713020242ACCENTA01532016-09-22
10817713020259ACCENTA01542016-09-22
10817713020327ACCENTA02002016-09-22
10817713020334ACCENTA02012016-09-22
10817713020341ACCENTA02022016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006522210868083M™ Unitek™ Metal Brackets3M UNITEK CORPORATIONDYH2026-05-07
006522212281543M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212282223M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282533M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282603M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282913M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283073M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283763M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284063M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284133M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212998263M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998333M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998403M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998573M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998643M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998713M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998883M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998953M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522213074393M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
006522213074463M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
00190746061318No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061325No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061332No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061370Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061394Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061400Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061417Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061431Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061455Porcelain ConditionerAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061516MR Lock LCAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10