Clearmet 1009225

GUDID H6681009225

Small Dental Device Extrusion Pellets

Keystone Industries

Dental appliance fabrication material, thermoplastic

• Primary Device ID: H6681009225
• NIH Device Record Key: 813e7214-60a9-4ee7-b947-65861556e290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearmet
• Version Model Number: 1009225
• Catalog Number: 1009225
• Company DUNS: 073503117
• Company Name: Keystone Industries
• Device Count: 5
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 25.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H6681009225 [Primary]
HIBCC	H66810092250 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152051

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 [Clearmet]

• H66810092291: Clearmet Dental Appliance Extrusion Pellets, bulk bag
• H6681009227: Medium Dental Device Extrusion Pellets
• H6681009225: Small Dental Device Extrusion Pellets