FDA.reportPublic FDA data

ORAPRO

Primary DI
00817713022942
Brand
ORAPRO
Company
ORTHOQUEST, INC.
Model
J801K
Catalog number
J801K
Device description
ORAPRO G2 LC ADHESIVE INTRO KIT 1/5GM SYRINGE
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
00817713022942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817713022942008177130229428177130229420817713022942

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192699952
Device count
1
Kit
true
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
10817713022970ORAPROJ815J8152017-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062605SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062612SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062629SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062636SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062643SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062650SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062667SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062674SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062766SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062773SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062780SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062797SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062865SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062872SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062896SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064739SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064746SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067891SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067907SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067914SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067921SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067938SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067945SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067952SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067969SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067976SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067983SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069208SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069215SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069222SolventumSolventum Orthodontics CorporationDYH2026-11-04