PERMASOFT

GUDID 00842326101975

SEALER, 30ml

The Myerson Company Limited

Denture reliner, soft, professional

• Primary Device ID: 00842326101975
• NIH Device Record Key: 8d7a769e-4a08-49b9-b33a-96f0a42d64a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERMASOFT
• Version Model Number: PSSEAL-30
• Company DUNS: 857278431
• Company Name: The Myerson Company Limited
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326101975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933468

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [PERMASOFT]

• 00842326102002: 60g KIT containing pink powder, liquid and sealer
• 00842326101999: 60g KIT containing clear powder, liquid and sealer
• 00842326101982: LIQUID, 60ml
• 00842326101975: SEALER, 30ml
• 00842326101968: POWDER, CLEAR, 60g
• 00842326101951: POWDER, PINK, 60g