BOSWORTH 16670R

GUDID H66816670R1

PROPHY BRITE AIR POLISHER-RED

Keystone Industries

Dental abrasive air jet system handpiece

• Primary Device ID: H66816670R1
• NIH Device Record Key: a3c69306-deb2-4e8a-afe6-bf6059c50fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOSWORTH
• Version Model Number: 16670R
• Catalog Number: 16670R
• 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	H66816670R1 [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)