Proflex 9146430

GUDID H66891464301

NFC Medium Resin

Keystone Industries

Dental appliance fabrication material, cured

• Primary Device ID: H66891464301
• NIH Device Record Key: a92c47cc-9a48-46d5-9083-37394c5e79e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proflex
• Version Model Number: 9146430
• Catalog Number: 9146430
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Dimensions

• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram
• Weight: 960 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66891464301 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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