ProTech SuperBond SBA12

GUDID D814SBA121

ProTech SuperBond Kit - 120 ml superbond and 120 ml thinner

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814SBA121
• NIH Device Record Key: 85dcbb85-71c3-4a28-adee-3bd317ef0b50
• Commercial Distribution Discontinuation: 2017-05-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ProTech SuperBond
• Version Model Number: SBA12
• Catalog Number: SBA12
• Company DUNS: 117374900
• Company Name: PROTECH PROFESSIONAL PRODUCTS 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D814SBA121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151646

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-20
• Device Publish Date: 2016-08-29

On-Brand Devices [ProTech SuperBond]

• D814SRSB1: 15 ml superbond
• D814SBT121: 120 ml ProTech Thinner
• D814SBT111: 60 ml ProTech Thinner
• D814SBL121: 120 ml ProTech Superbond
• D814SBL111: 60 ml ProTech SuperBond
• D814SBA121: ProTech SuperBond Kit - 120 ml superbond and 120 ml thinner
• D814SBA111: ProTech SuperBond Kit - 60 ml superbond and 60 ml thinner