Lynx Scalemaster

GUDID D826LX3004H021

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

MTI Precision Products, LLC

Rotary dental scaler

• Primary Device ID: D826LX3004H021
• NIH Device Record Key: 72f3699d-e23e-42c9-966f-a947e22f4635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lynx Scalemaster
• Version Model Number: LX3004H02
• Company DUNS: 081600128
• Company Name: MTI Precision Products, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D826LX3004H020 [Direct Marking]
HIBCC	D826LX3004H021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901488

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

[D826LX3004H021]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Lynx Scalemaster]

• D826LX3004H090: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3004H040: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3004H031: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3004H021: The Lynx Scalemaster is an ultrasonic scaler is a device intended for use during dental cleaning
• D826LX3002H090: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3002H040: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3002H031: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an
• D826LX3002H021: The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning an