PRIMER

GUDID D82813302550

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: D82813302550
• NIH Device Record Key: 69b41248-ef37-453b-9cf8-e3d83c1f17ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMER
• Version Model Number: 1330255
• Company DUNS: 113352686
• Company Name: FIVE STAR ORTHODONTIC LABORATORY & SUPPLY 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: false
• 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
HIBCC	D82813302550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071688

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

• D82851001560 - Bioliner Plus: 2023-02-20
• D82852000920 - Vivos mmRNA: 2021-11-29
• D8281330003 - FUJI SC BAND PASTE PAK: 2018-07-06
• D8281330121 - FUJI LC BAND AUTOMIX: 2018-07-06
• D8281330171 - ULTRA BAND LOK CLEAR: 2018-07-06
• D8281330205 - LIGHT BOND PASTE TIPS: 2018-07-06
• D8281330206 - SKINNY NOSE LIGHT BOND PASTE TIPS: 2018-07-06
• D82813302070 - LIGHT BOND SYRINGE: 2018-07-06