FDA.reportPublic FDA data

ORAPRO

Primary DI
10817713022987
Brand
ORAPRO
Company
ORTHOQUEST, INC.
Model
J840
Catalog number
J840
Device description
ORAPRO G2 LC ADJHESIVE .35G UNIT DOSE
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10817713022987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081771302298710817713022987

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
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
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