FDA.reportPublic FDA data

ORAPRO

Primary DI
00817713022997
Brand
ORAPRO
Company
ORTHOQUEST, INC.
Model
J906K
Catalog number
J906K
Device description
ORAPRO G2 LC BAND CEMENT BLUE KIT 6/5GM
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942596000ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENTWallace A. Erickson & Co.1994-06-16EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817713022997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817713022997008177130229978177130229970817713022997

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

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
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20