Comfort-Sonic K-7

GUDID 00990010306639

Woodpecker: GK3, For removal of large areas of supragingival calculus

Beyes Dental Canada Inc

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system

• Primary Device ID: 00990010306639
• NIH Device Record Key: 52a1a207-1d9e-4db5-a832-aa19dae33643
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort-Sonic
• Version Model Number: UL2212
• Catalog Number: K-7
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990010306639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053555

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

[00990010306639]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-05
• Device Publish Date: 2023-12-28

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• 00837699000840: COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE
• 00990010302037: COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE
• 00990010302020: Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1)
• 00990010302013: Comfort-Sonic LED Scalers P9, includes 8 tips ( EE1, EG1, EG4, EG5, EG6, EP1, EP3, EP4D), 1 tip
• 00990010306646: Woodpecker: GK4 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p
• 00990010306639: Woodpecker: GK3, For removal of large areas of supragingival calculus
• 00990010306622: Woodpecker: GK2 , For removal of large areas of supragingival calculus
• 00990010306615: Woodpecker: GK1, For removal of large areas of calculus
• 00990010306738: Woodpecker: GK20 , for “supragingival shoulder” preparation after the completion of the prep
• 00990010306721: Woodpecker: EK8, For root canal enlargement and cleaning
• 00990010306714: Woodpecker: GK11 , For orthodontic
• 00990010306707: Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p
• 00990010306691: Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in po
• 00990010306684: Woodpecker: GK5, Gentle pocket cleansing during periodontal treatment; effective cleansing in po
• 00990010306677: Woodpecker: PC1 , Sickle scaler type for removal of supragingival calculus. The diamond-shaped c
• 00990010306660: Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the nec
• 00990010306653: Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical t