Deldent 508804

GUDID 10816577022393

DP 100 THIN STRAIGHT 25K METAL ULTRASONIC INSERTS

Young Innovations, Inc.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 10816577022393
• NIH Device Record Key: 9acde867-33bc-405e-b2b1-d5a908c3dce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deldent
• Version Model Number: 508804
• Catalog Number: 508804
• Company DUNS: 004193103
• Company Name: Young Innovations, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com
• Phone: +1 (800) 210-8945
• Email: customerservice@younginnovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816577022396 [Primary]
GS1	10816577022393 [Package]; Contains: 00816577022396; Package: INNER PACK [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011179

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

[10816577022393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-02
• Device Publish Date: 2022-11-24

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• 10840326418588: DF 1000 TRIPLE BEND 30K ULTRASONIC INSERTS
• 10840326418571: DF 100 THIN STRAIGHT 30K ULTRASONIC INSERTS
• 10840326418564: DF 10 UNIVERSAL 30K ULTRASONIC INSERTS
• 10840326418557: DF 3 FLAT 30K ULTRASONIC INSERTS
• 10840326418540: DF 1000 TRIPLE BEND 25K ULTRASONIC INSERTS
• 10840326418533: DF 100 THIN STRAIGHT 25K ULTRASONIC INSERTS
• 10840326418526: DF 10 UNIVERSAL 25K ULTRASONIC INSERTS
• 10840326418519: DF 3 FLAT 25K ULTRASONIC INSERTS
• 10816577022737: DP 100 THIN STRAIGHT 30K METAL ULTRASONIC INSERTS
• 10816577022676: DP 10 UNIVERSAL 30K METAL ULTRASONIC INSERTS
• 10816577022393: DP 100 THIN STRAIGHT 25K METAL ULTRASONIC INSERTS
• 10816577021594: DP 10 UNIVERSAL 25K METAL ULTRASONIC INSERTS
• 10816577020351: ALUMINUM OXIDE POWDER 50 MICRON 2 POUND BOTTLE