FDA.reportPublic FDA data

MR Lock LC

Primary DI
00190746061516
Brand
MR Lock LC
Company
AMERICAN ORTHODONTICS CORPORATION
Model
001-975
Catalog number
001-975
Device description
MR LOCK BAND CEMENT 50/PK
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K001446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001446000LIGHT-CURED ORTHODONTIC BAND CEMENTScientific Pharmaceuticals, Inc.2000-07-21DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746061516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746061516001907460615161907460615160190746061516

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 Temperature2 Degrees Celsius24 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
044668515
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
00190746189258Buccal Tubes851-110851-1102022-03-24
00190746189272Buccal Tubes851-121851-1212022-03-24
00190746189432Buccal Tubes851-182851-1822022-03-24
00190746141249Stainless Steel Brackets002-0070HMURWF002-0070HMURWF2021-09-03
00190746141263Stainless Steel Brackets002-0071HMULWF002-0071HMULWF2021-09-03
00190746141454Stainless Steel Brackets002-477HDLLWF002-477HDLLWF2021-09-03
00190746141461Stainless Steel Brackets002-477HDLRWF002-477HDLRWF2021-09-03
00190746141515Stainless Steel Brackets002-494HDLLWF002-494HDLLWF2021-09-03
00190746141522Stainless Steel Brackets002-494HDLRWF002-494HDLRWF2021-09-03
00190746175442Stainless Steel Brackets092-208BUL092-208BUL2021-09-03
00190746175459Stainless Steel Brackets092-208BUR092-208BUR2021-09-03
00190746176296Stainless Steel Brackets097-211UL097-211UL2021-09-03
00190746176302Stainless Steel Brackets097-211UR097-211UR2021-09-03
00190746177996Stainless Steel Brackets593-004593-0042021-09-03
00190746161575Stainless Steel Brackets091-142BUL091-142BUL2021-08-26
00190746174957Stainless Steel Brackets091-142BUR091-142BUR2021-08-26
00190746175268Stainless Steel Brackets092-006BUL092-006BUL2021-08-26
00190746175275Stainless Steel Brackets092-006BUR092-006BUR2021-08-26
00190746175503Stainless Steel Brackets092-444HDLR092-444HDLR2021-08-26
00190746175510Stainless Steel Brackets092-445HDLL092-445HDLL2021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190746061400Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10