Signature Custom Orthodontic Braces

GUDID 00860270000953

Patient Specific Orthodontic Brackets with Indirect Bonding Jigs Materal: Polycrystal Alumina Color: White

LIGHTFORCE ORTHODONTICS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00860270000953
• NIH Device Record Key: e346da1a-00de-4ad1-b9ec-e25949589b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature Custom Orthodontic Braces
• Version Model Number: 08.23.18.1.PCA.TBW.WJ
• Company DUNS: 096883072
• Company Name: LIGHTFORCE ORTHODONTICS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	00860270000953 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-05
• Device Publish Date: 2018-08-23