FDA.reportPublic FDA data

Carriere® Motion Pro™

Primary DI
10190707103009
Brand
Carriere® Motion Pro™
Company
ORTHO ORGANIZERS, INC.
Model
425-820C
Device description
Carriere® Motion Pro™ Clear Bite Corrector 20 mm Set
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160720000Carriere Motion Clear Class IIOrtho Organizers, Inc.2016-11-28DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707103002PrimaryGS10
10190707103009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707103002001907071030021907071030020190707103002
1019070710300910190707103009

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
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
D829665016200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665016200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665020200M0051Premium LineEC Certification Service GmbHDYW2026-05-28