FDA.reportPublic FDA data

BracePaste

Primary DI
00190746134388
Brand
BracePaste
Company
AMERICAN ORTHODONTICS CORPORATION
Model
020-033120
Catalog number
020-033120
Device description
ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 2/PK
Published
2020-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K160782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160782000BracePaste AdhesiveAmerican Orthodontics2016-10-14DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746134388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746134388001907461343881907461343880190746134388

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746062896BracePaste Fluoride Sealant Kit020-039668020-0396682024-10-28
00190746188800BracePaste Fluoride Sealant020-035993020-0359932024-10-10
00190746059193BracePaste020-026877020-0268772022-10-05
00190746059209BracePaste020-026878020-0268782022-10-05
00190746059216BracePaste020-026879020-0268792022-10-05
00190746059223BracePaste020-026880020-0268802022-10-05
00190746059254BracePaste MTP Light Cure Primer020-029614020-0296142022-10-05
00190746059261BracePaste MTP Kit020-030089020-0300892022-10-05
00190746059285BracePaste020-031573020-0315732022-10-05
00190746059292BracePaste020-031574020-0315742022-10-05
00190746059322BracePaste020-031575020-0315752022-10-05
00190746059339Bracepaste Band and Build LC020-032026020-0320262022-10-05
00190746059346Bracepaste Band and Build LC020-032027020-0320272022-10-05
00190746059476Carbide BurFG118LFG118L2022-10-05
00190746059506Carbide BurFG118SFG118S2022-10-05
00190746059513Carbide BurFG218FG2182022-10-05
00190746059520Carbide BurFG283-014FG283-0142022-10-05
00190746059551Diamond BurFG392-016FFG392-016F2022-10-05
00190746059568Carbide BurFG699LFG699L2022-10-05
00190746059575Carbide BurFG7675FG76752022-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746134432BracePaste Prime PlusAMERICAN ORTHODONTICS CORPORATIONDYH2026-09-29
08809262950823OrthoFitSpident Co., Ltd.DYH2026-07-14
08809262957983OrthoFitSpident Co., Ltd.DYH2026-07-14
08809262957990OrthoFitSpident Co., Ltd.DYH2026-07-14
00371347022292Advance Dental ProductsThe Atlanta Dental Supply CompanyDYH2026-07-08
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