FDA.reportPublic FDA data

FlexBracket

Primary DI
00850079555624
Brand
FlexBracket
Company
LIGHTFORCE ORTHODONTICS, INC.
Model
09.01.25.PCA.FB.UL5.022
Device description
FlexBracket PCA UL5 022 -11 0 Hook
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232827000LightForce Orthodontic SystemLightforce Orthodontics2023-09-14NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850079555624PrimaryGS10
10850079555621Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850079555624008500795556248500795556240850079555624
1085007955562110850079555621

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
096883072
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850079555587FlexBracket09.01.25.PCA.FB.UL1.0222025-10-14
00850079555594FlexBracket09.01.25.PCA.FB.UL2.0222025-10-14
00850079555600FlexBracket09.01.25.PCA.FB.UL3.0222025-10-14
00850079555617FlexBracket09.01.25.PCA.FB.UL4.0222025-10-14
00850079555631FlexBracket09.01.25.PCA.FB.UL6.0222025-10-14
00850079555648FlexBracket09.01.25.PCA.FB.UL7.0222025-10-14
00850079555655FlexBracket09.01.25.PCA.FB.UR1.0222025-10-14
00850079555662FlexBracket09.01.25.PCA.FB.UR2.0222025-10-14
00850079555679FlexBracket09.01.25.PCA.FB.UR3.0222025-10-14
00850079555686FlexBracket09.01.25.PCA.FB.UR4.0222025-10-14
00850079555693FlexBracket09.01.25.PCA.FB.UR5.0222025-10-14
00850079555709FlexBracket09.01.25.PCA.FB.UR6.0222025-10-14
00850079555716FlexBracket09.01.25.PCA.FB.UR7.0222025-10-14
00850079555723FlexBracket09.01.25.PCA.FB.LL1.0222025-10-14
00850079555730FlexBracket09.01.25.PCA.FB.LL2.0222025-10-14
00850079555747FlexBracket09.01.25.PCA.FB.LL3.0222025-10-14
00850079555754FlexBracket09.01.25.PCA.FB.LL4.0222025-10-14
00850079555761FlexBracket09.01.25.PCA.FB.LL5.0222025-10-14
00850079555778FlexBracket09.01.25.PCA.FB.LL6.0222025-10-14
00850079555785FlexBracket09.01.25.PCA.FB.LL7.0222025-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210067PROMO KIT ICERAM-P ROTH 0.022ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2024-04-16
08800046016025VAR-18-301GNI Co.,LtdNJM2022-12-14
08800046016032VAR-18-331GNI Co.,LtdNJM2022-12-14
08800046016049VAR-18-051GNI Co.,LtdNJM2022-12-14
08800046016056VAR-18-501GNI Co.,LtdNJM2022-12-14
08800046016063VAR-18-551GNI Co.,LtdNJM2022-12-14
08800046016070VAR-18-053GNI Co.,LtdNJM2022-12-14
08800046016087VAR-18-503GNI Co.,LtdNJM2022-12-14
08800046016094VAR-18-553GNI Co.,LtdNJM2022-12-14
08800046016100VAR-22-031GNI Co.,LtdNJM2022-12-14
08800046016117VAR-22-301GNI Co.,LtdNJM2022-12-14
08800046016124VAR-22-331GNI Co.,LtdNJM2022-12-14
08800046016131VAR-22-051GNI Co.,LtdNJM2022-12-14
08800046016148VAR-22-501GNI Co.,LtdNJM2022-12-14
08800046016155VAR-22-551GNI Co.,LtdNJM2022-12-14
08800046016162VAR-22-053GNI Co.,LtdNJM2022-12-14
08800046016179VAR-22-503GNI Co.,LtdNJM2022-12-14
08800046016193VAM-18-031GNI Co.,LtdNJM2022-12-14
08800046016209VAM-18-301GNI Co.,LtdNJM2022-12-14
08800046016216VAM-18-331GNI Co.,LtdNJM2022-12-14
08800046016223VAM-18-051GNI Co.,LtdNJM2022-12-14
08800046016230VAM-18-501GNI Co.,LtdNJM2022-12-14
08800046016247VAM-18-551GNI Co.,LtdNJM2022-12-14
08800046016254VAM-18-053GNI Co.,LtdNJM2022-12-14
08800046016261VAM-18-503GNI Co.,LtdNJM2022-12-14
08800046016278VAM-18-553GNI Co.,LtdNJM2022-12-14
08800046016285VAM-22-031GNI Co.,LtdNJM2022-12-14
08800046016292VAM-22-301GNI Co.,LtdNJM2022-12-14
08800046016308VAM-22-331GNI Co.,LtdNJM2022-12-14
08800046016315VAM-22-051GNI Co.,LtdNJM2022-12-14