PIT AND FISSURE SEALANT OP

GUDID D8281330229

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Dental pit/fissure sealant

• Primary Device ID: D8281330229
• NIH Device Record Key: 727d14a4-3191-4bb6-be32-0118eff338ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIT AND FISSURE SEALANT OP
• Version Model Number: 1330229
• Company DUNS: 113352686
• Company Name: FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
• Device Count: 4
• 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	D8281330229 [Primary]
HIBCC	D82813302292 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093059

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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

• D82850001900 - Twin Block: 2024-10-21
• D82853004020 - Rickonator: 2024-10-21
• 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