FDA.reportPublic FDA data

Carriere® Motion Pro™

Primary DI
00190707103064
Brand
Carriere® Motion Pro™
Company
Ortho Organizers, Inc.
Model
425-825C
Device description
Carriere® Motion Pro™ Clear Bite Corrector 25 mm 1-Set
Published
2024-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2
EJFBracket, Metal, OrthodonticDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252760000Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.2025-11-27DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707103064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707103064001907071030641907071030640190707103064

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190746175954Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
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00190746175978Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175985Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
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00190746176166Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176753Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176760Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176951Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176968Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177132Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177149Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177156Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177163Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26