DENTALAIRE Dentalaire LED kit

GUDID 00990010306332

DA400LEDMH, LED High Speed Handpiece Retrofit any air powered dental station with LED lighting

Beyes Dental Canada Inc

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• Primary Device ID: 00990010306332
• NIH Device Record Key: 169a133a-b22f-41ea-b4f4-1b1312922ff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTALAIRE
• Version Model Number: DA400LEDMH
• Catalog Number: Dentalaire LED kit
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00990010306332 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

[00990010306332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-04
• Device Publish Date: 2023-12-27

Devices Manufactured by Beyes Dental Canada Inc

• 00990010306653 - Comfort-Sonic: 2024-01-29 Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical thirds of large and straight cana
• 00990010306660 - Comfort-Sonic: 2024-01-29 Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the neck of the teeth
• 00990010306677 - Comfort-Sonic: 2024-01-29 Woodpecker: PC1 , Sickle scaler type for removal of supragingival calculus. The diamond-shaped cross-section allows efficient sc
• 00990010306684 - Comfort-Sonic: 2024-01-29 Woodpecker: GK5, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; for the a
• 00990010306691 - Comfort-Sonic: 2024-01-29 Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from firs
• 00990010306707 - Comfort-Sonic: 2024-01-29 Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from sec
• 00990010306714 - Comfort-Sonic: 2024-01-29 Woodpecker: GK11 , For orthodontic
• 00990010306721 - Comfort-Sonic: 2024-01-29 Woodpecker: EK8, For root canal enlargement and cleaning