Duraflex

GUDID 00842326104211

Pink Disc, 98mm x 25mm

The Myerson Company Limited

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 00842326104211
• NIH Device Record Key: 502ff56e-a573-43da-9486-5ed90d7323f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duraflex
• Version Model Number: DFDISC-PNK-98-25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326104211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063626

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-14

On-Brand Devices [Duraflex]

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• 00842326104297: Tissue Tone Pink Disc, 98mm x 20mm
• 00842326104280: Tissue Tone Pink Disc, 98mm x 15mm
• 00842326104273: Medium Pink Disc, 98mm x 25mm
• 00842326104266: Medium Pink Disc, 98mm x 20mm
• 00842326104259: Medium Pink Disc, 98mm x 15mm
• 00842326104211: Pink Disc, 98mm x 25mm
• 00842326104204: Pink Disc, 98mm x 20mm
• 00842326104198: Pink Disc, 98mm x 15mm
• 00842326102491: Dark Pink Single Shot 6pk Thermoplastic Resin Material
• 00842326102477: TTP, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102460: TTP, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102453: TTP, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102446: TTP 400g Jar Thermoplastic Resin Material
• 00842326102439: TTP 12.5kg Bulk Thermoplastic Resin Material
• 00842326102422: IPR Single Shot 6pk Thermoplastic Resin Material
• 00842326102408: TRU Pink, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102392: TRU Pink, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102385: TRU Pink, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102378: TRU Pink 400g Jar Thermoplastic Resin Material
• 00842326102361: TRU Pink 12.5kg Bulk Thermoplastic Resin Material
• 00842326102354: IUSD Single Shot 6pk Thermoplastic Resin Material
• 00842326102330: Pink, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102323: Pink, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102316: Pink, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102309: Pink 400g Jar Thermoplastic Resin Material
• 00842326102293: Pink 12.5kg Bulk Thermoplastic Resin Material
• 00842326102286: Medium Pink Single Shot 6pk Thermoplastic Resin Material
• 00842326102262: Medium Pink, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102255: Medium Pink, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102248: Medium Pink, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102231: Medium Pink 400g Jar Thermoplastic Resin Material
• 00842326102224: Medium Pink 12.5kg Bulk Thermoplastic Resin Material
• 00842326102217: Pink Single Shot 6pk Thermoplastic Resin Material
• 00842326102194: IUSD, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102187: IUSD, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102170: IUSD, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102163: IUSD 400g Jar Thermoplastic Resin Material
• 00842326102156: IUSD 12.5kg Bulk Thermoplastic Resin Material
• 00842326102149: TRU Pink Single Shot 6pk Thermoplastic Resin Material
• 00842326102125: IPR, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102118: IPR, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102101: IPR, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102095: IPR 400g Jar Thermoplastic Resin Material
• 00842326102088: IPR 12.5kg Bulk Thermoplastic Resin Material
• 00842326102071: TTP Single Shot 6pk Thermoplastic Resin Material
• 00842326102057: Dark Pink, Small Cartridge 6pk Thermoplastic Resin Material
• 00842326102040: Dark Pink, Medium Cartridge 6pk Thermoplastic Resin Material
• 00842326102033: Dark Pink, Large Cartridge 6pk Thermoplastic Resin Material
• 00842326102026: Dark Pink 400g Jar Thermoplastic Resin Material