BOSWORTH

Basic Information

• Brand Name: BOSWORTH
• Primary DI: H668166361
• Version / Model: 16636
• Catalog Number: 16636
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: fb489c67-0aaa-410b-9e23-b22d22ba2c68

Device Description

PROPHY PDWR 3oz TRI PAK (16633, 16635, 16694)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY	Dental	872.6030	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45407	Professional dental abrasive material	A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	H668166360	HIBCC
Primary	H668166361	HIBCC

Customer Contacts

• Phone: [phone] ext. 8455
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from moisture
• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit