FDA.report

Carriere

Primary DI
00190707022945
Brand
Carriere
Company
ORTHO ORGANIZERS, INC.
Model
424-900CN
Device description
Carriere® MOTION 3D COLORS™ Class II Trial Kit (23,25,27mm)-Silver
Published
2017-09-08
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
true

Related Records

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707022945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707022945001907070229451907070229450190707022945

GMDN Terms

TermDefinition
Orthodontic appliance system, adjustableAn assembly of devices such as metal bands, archwires, springs and/or power arms, designed to influence the shape and/or function of the stomatognathic system. Once applied to the teeth, it may be periodically adjusted to effect skeletal and/or dental changes by modifying and utilizing the neuromuscular forces of the stomatognathic system. It is typically used to correct malocclusions such as underbites, overbites, and cross bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. Commonly known as a dental brace or orthodontic brace, it is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00190707086503Triumph®205-206B2026-01-07
10190707086517Triumph®205-206T2026-01-07
10190707086524Triumph®205-207T2026-01-07
10190707086531Triumph®205-207TT2026-01-07
00190707102975Carriere® Motion Pro™425-818C2024-01-16
00190707103002Carriere® Motion Pro™425-820C2024-01-16
00190707103033Carriere® Motion Pro™425-823C2024-01-16
00190707103064Carriere® Motion Pro™425-825C2024-01-16
00190707103095Carriere® Motion Pro™425-827C2024-01-16
00190707075972Maestro® Band Assemblies902-351061E2020-07-14
00190707096755Reveal® Aligners139-61042022-01-06
00190707096762Reveal® Aligners139-61052022-01-06
00190707096779Reveal® Aligners139-61062022-01-06
00190707096786Reveal® Aligners139-61072022-01-06
00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908470707678KIT LAUNCH - U-CLIPORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211286METAL BRACKET U-CLIP INTERACTIVE MBT 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211859METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U1RL - (11/21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211866METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3L/L3R (23/43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211873METAL BRACKET PREMIUM ELITE MBT 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212689METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212696METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213525METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - (12/22/31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213570METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3R/L3L (13/33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213921METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U3RL/U45RL/L345L/L345R - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611215253METAL BRACKET U-CLIP DUAL PLUS – 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191626Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23