BOSWORTH 16670LB

GUDID H66816670LB1

PROPHY BRITE AIR POLISHER-LT BLUE

Keystone Industries

Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece

• Primary Device ID: H66816670LB1
• NIH Device Record Key: bd37ad67-24cf-4e77-a321-d5753bd5423b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOSWORTH
• Version Model Number: 16670LB
• Catalog Number: 16670LB
• 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: false
• Serial Number: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	H66816670LB1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100731

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [BOSWORTH]

• H668166960: PROPHY PWDR 3oz TRI PAK (16693,16694 & 16695)
• H668166921: PROPHY POWDER ORANGE (10 OZ)
• H66816691B1: PROPHY POWDER MINT (1 LB BULK)
• H668166911: PROPHY POWDER MINT (10 OZ)
• H668166901: PROPHY POWDER GRAPE (10 OZ)
• H66816677C1: PROPHY BRITE AIR POLISHER NOZZLE
• H66816670R1: PROPHY BRITE AIR POLISHER-RED
• H66816670N1: PROPHY BRITE AIR POLISHER-ORANGE
• H66816670LB1: PROPHY BRITE AIR POLISHER-LT BLUE
• H66816670B1: PROPHY BRITE AIR POLISHER-BLACK
• H668166530: GREEN EVACUATORS (100)
• H668166520: BLUE EVACUATORS (100)
• H668166510: WHITE EVACUATORS (100)
• H668166360: PROPHY PDWR 3oz TRI PAK (16633, 16635, 16694)
• H668166321: PROPHY POWDER LEMONLIME (10OZ)
• H668166301: PROPHY POWDER STRAWBERRY(10OZ)
• H66809218670: DISPOSABLE PLASTIC SYRINGE (50)
• H66809214890: WONDER WEDGES (500) Assorted Colors, sizes
• H66809214880: WONDER WEDGES (500) 17MM Ex Lg Bleached
• H66809214870: WONDER WEDGES (500)15MM Lg YELLOW
• H66809214860: WONDER WEDGES (500) 13MM Med GREEN
• H66809214850: WONDER WEDGES (500) 12MM Small BLUE
• H66809214840: WONDER WEDGES (100) Assorted Colors, sizes
• H66809214830: WONDER WEDGES (100)17MM Ex Lg Bleached
• H66809214820: WONDER WEDGES (100)15MM Lg YELLOW
• H66809214810: WONDER WEDGES (100) 13MM Med GREEN
• H66809214800: WONDER WEDGES (100)12MM Small BLUE
• H66809214260: WONDER WEDGES Assorted, Natural (500)
• H66809214250: WONDER WEDGES 17MM Ex Lg Natural (500)
• H66809214240: WONDERS WEDGES 15MM Lg Natural (500)
• H66809214230: WONDER WEDGES-13MM Med, Natural (500)
• H66809214220: WONDER WEDGES 12MM Small, Natural (500)
• H66809214210: WONDER WEDGES Assorted, Natural (100)
• H66809214200: WONDER WEDGES -17MM Ex Lg Natural (100)
• H66809214190: WONDER WEDGES 15MM Lg Natural (100)
• H66809214180: WONDER WEDGES-13MM Med, Natural (100)
• H66809214170: WONDER WEDGES-12MM Small, Natural (100)