FDA.reportPublic FDA data

NA

Primary DI
00817573023035
Brand
NA
Company
LANCER ORTHODONTICS, INC.
Model
810-525
Device description
PASTE-FORMULA 10 .35g TIP 57/PK
Published
2017-01-12
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
K904090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904090000ORTHODONTIC BONDING ADHESIVE CONTROLLancer Orthodontics, Inc.1991-04-29DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817573023035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817573023035008175730230358175730230350817573023035

GMDN Terms#

Term, Definition table
TermDefinition
Fatty acid dental cementA non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature37 Degrees Fahrenheit50 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045545589
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817573022816NA551-4022017-01-12
00817573022823NA551-402RM2017-01-12
00817573022830NA551-4032017-01-12
00817573022847NA551-403RM2017-01-12
00817573022878NA551-7352017-01-12
00817573022885NA551-9252017-01-12
00817573024551NASAMS122017-01-15
00817573022892NA810-2112017-01-12
00817573022977NA810-5022017-01-12
00817573022984NA810-5032017-01-12
00817573022991NA810-5102017-01-12
00817573023004NA810-5222017-01-12
00817573023011NA810-5232017-01-12
00817573023028NA810-5242017-01-12
00817573023042NA810-5262017-01-12
00817573023059NA810-5272017-01-12
00817573023066NA810-5282017-01-12
00817573023073NA810-5292017-01-12
00817573023189Rely-a-Bond811-0022017-01-12
00817573023196Rely-a-Bond811-0052017-01-12

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