Bosworth Gorilla Seal 0921051

GUDID H66809210511

LC Sealant Refill

Harry J Bosworth Company

Dental unfilled resin sealant/coating

• Primary Device ID: H66809210511
• NIH Device Record Key: ff163eac-489d-4fd7-a43a-8530625c9f9b
• Commercial Distribution Discontinuation: 2019-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bosworth Gorilla Seal
• Version Model Number: 0921051
• Catalog Number: 0921051
• Company DUNS: 014769301
• Company Name: Harry J Bosworth Company
• Device Count: 4
• 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: 1.2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809210510 [Unit of Use]
HIBCC	H66809210511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051224

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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: 2019-12-23
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Gorilla Seal]

• H66809210511: LC Sealant Refill
• H66809210501: LC Sealant 6 ml Intro Pack