Proflex 9640360

GUDID H66896403600

Pro-flex Clear Wire Clasp Material

Keystone Industries

Denture clasp, polymer, preformed

• Primary Device ID: H66896403600
• NIH Device Record Key: add597fc-3390-4841-a03e-4e78906685c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proflex
• Version Model Number: 9640360
• Catalog Number: 9640360
• Company DUNS: 073503117
• Company Name: Keystone Industries
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66896403600 [Unit of Use]
HIBCC	H66896403601 [Primary]

FDA Product Code

• EHP: CLASP, PREFORMED

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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Proflex]

• H66891465751: Flexible NFC Liquid 120g
• H66891465701: Flexible NFC Liquid 240g
• H66891465601: NFC Medium Super Econo Kit
• H66891465511: NFC Medium Resin
• H66891465401: NFC Light Super Econo Kit
• H66891465351: NFC Light Resin
• H66891465101: NFC Firm Clear Resin
• H66891464901: NFC Dark Super Econo Kit
• H66891464851: NFC Dark Resin
• H66891464701: NFC Clear Super Econo Kit
• H66891464651: NFC Clear Resin
• H66891464301: NFC Medium Resin
• H66891463901: NFC Light Resin
• H66891462001: NFC Clear Resin
• H66896403600: Pro-flex Clear Wire Clasp Material
• H66896410001: NFC Medium Super Econo Kit
• H66896408901: NFC Clear Super Econo Kit