Lynx Scalemaster

Basic Information

• Brand Name: Lynx Scalemaster
• Primary DI: D826LX3002H021
• Version / Model: LX3002H02
• Company Name: MTI Precision Products, LLC
• Labeler DUNS: 081600128
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2022-03-23
• Public Version Status: Update
• Public Device Record Key: 16df14a9-8557-4709-acc9-2d8e3a9597c9
• Distribution End Date: 2021-12-31

Device Description

The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits for teeth by application of a sonic vibrating scaler tip to the teeth.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31885	Rotary dental scaler	An abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D826LX3002H021	HIBCC
Direct Marking	D826LX3002H020	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K901488	000