Bosworth Aegis 0921328

GUDID H66809213281

Aegis Pit & Fissure Sealant w/ACP Refill Kit

Harry J Bosworth Company

Dental pit/fissure sealant

• Primary Device ID: H66809213281
• NIH Device Record Key: 1409cacd-8c02-46e2-aa4e-dcaf039ca06e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Aegis
• Version Model Number: 0921328
• Catalog Number: 0921328
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809213280 [Unit of Use]
HIBCC	H66809213281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033751

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

On-Brand Devices [Bosworth Aegis]

• H66809213481: Aegis Pit & Fissure Sealant w/ACP Standard Kit
• H6680921328S1: Aegis Pit & Fissure Sealant w/ACP 0.4 mL Sample
• H66809213281: Aegis Pit & Fissure Sealant w/ACP Refill Kit
• H66809213271: Aegis Pit & Fissure Sealant w/ACP Clinic Kit