FlexBracket

GUDID 00850079555112

FlexBracket PCA UR5 022 -11 0 Hook

LIGHTFORCE ORTHODONTICS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00850079555112
• NIH Device Record Key: 3e995af1-ee88-4b13-8bc9-77ccc72e57da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexBracket
• Version Model Number: 09.01.25.PCA.FB.UR5.022
• Company DUNS: 096883072
• Company Name: LIGHTFORCE ORTHODONTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850079555112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232827

FDA Product Code

• NJM: Bracket, Ceramic, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-26

On-Brand Devices [FlexBracket]

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