FlexBracket

GUDID 00850079555242

FlexBracket PCA LR4 022 -14 0 Hook

LIGHTFORCE ORTHODONTICS, INC.

Orthodontic bracket, ceramic
Primary Device ID00850079555242
NIH Device Record Key6d13507c-38f3-4b59-aae3-4f348fc41a56
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexBracket
Version Model Number09.01.25.PCA.FB.LR4.022
Company DUNS096883072
Company NameLIGHTFORCE ORTHODONTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850079555242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

On-Brand Devices [FlexBracket]

00850079555273FlexBracket PCA LR7 022 -27 0 Hook
00850079555266FlexBracket PCA LR6 022 -27 0 Hook
00850079555259FlexBracket PCA LR5 022 -19 0 Hook
00850079555242FlexBracket PCA LR4 022 -14 0 Hook
00850079555235FlexBracket PCA LR3 022 -6 +7 Hook
00850079555228FlexBracket PCA LR2 022 -2 0
00850079555211FlexBracket PCA LR1 022 -1 0
00850079555204FlexBracket PCA LL7 022 -27 0 Hook
00850079555198FlexBracket PCA LL6 022 -27 0 Hook
00850079555181FlexBracket PCA LL5 022 -19 0 Hook
00850079555174FlexBracket PCA LL4 022 -14 0 Hook
00850079555167FlexBracket PCA LL3 022 -6 +7 Hook
00850079555150FlexBracket PCA LL2 022 -2 0
00850079555143FlexBracket PCA LL1 022 -1 0
00850079555136FlexBracket PCA UR7 022 -24 0 Hook
00850079555129FlexBracket PCA UR6 022 -21 0 Hook
00850079555112FlexBracket PCA UR5 022 -11 0 Hook
00850079555105FlexBracket PCA UR4 022 -7 0 Hook
00850079555099FlexBracket PCA UR3 022 0 +13 Hook
00850079555082FlexBracket PCA UR2 022 +7 +9
00850079555075FlexBracket PCA UR1 022 +11 +5
00850079555068FlexBracket PCA UL7 022 -24 0 Hook
00850079555051FlexBracket PCA UL6 022 -21 0 Hook
00850079555044FlexBracket PCA UL5 022 -11 0 Hook
00850079555037FlexBracket PCA UL4 022 -7 0 Hook
00850079555020FlexBracket PCA UL3 022 0 +13 Hook
00850079555013FlexBracket PCA UL2 022 +7 +9
00850079555006FlexBracket PCA UL1 022 +11 +5

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