Procure 9143160

GUDID H66891431601

Hard Reline Pwd

Keystone Industries

Denture reliner, hard

• Primary Device ID: H66891431601
• NIH Device Record Key: 9ac135b9-56b7-4084-9995-b540a46a189f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procure
• Version Model Number: 9143160
• Catalog Number: 9143160
• 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

Device Dimensions

• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram
• Weight: 180 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66891431601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864757

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: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-15

On-Brand Devices [Procure]

• H66891432401: Soft Reline Econo Kit
• H66891432101: Soft Reline Professional Kit
• H66891431701: Hard Reline Liquid
• H66891431601: Hard Reline Pwd
• H66891431301: Hard Reline Econo Kit
• H66891431001: Hard Reline Professional Kit
• H66871105091: Denture Reline Hard & Soft Intro Kit
• H66896347401: Hard Reline Econo Kit
• H66896346001: Procure Denture Reline Hard & Soft Intro Kit