Lynx Scalemaster

GUDID D826LX3004H031

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.

MTI Precision Products, LLC

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• Primary Device ID: D826LX3004H031
• NIH Device Record Key: 74600d0b-3949-4cbd-9956-b74c5678993c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lynx Scalemaster
• Version Model Number: LX3004H03
• 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	D826LX3004H030 [Direct Marking]
HIBCC	D826LX3004H031 [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

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

Moist Heat or Steam Sterilization

[D826LX3004H031]

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