Bosworth Re'cord 0921315

GUDID H66809213151

Polyvinylsiloxane Bite Registration Kit

Harry J Bosworth Company

Silicone dental impression material

• Primary Device ID: H66809213151
• NIH Device Record Key: 758e9569-2d59-490b-bef4-d8d6d060db57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Re'cord
• Version Model Number: 0921315
• Catalog Number: 0921315
• Company DUNS: 014769301
• Company Name: Harry J Bosworth Company
• Device Count: 2
• 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: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Dimensions

• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809213150 [Unit of Use]
HIBCC	H66809213151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926033

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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