Ultrasonic Scaler Insert 508801

GUDID 07290016281415

Magnetostrictive dental scaler insert

DELDENT LTD.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 07290016281415
• NIH Device Record Key: 979c0d9d-0f94-4163-bffd-ac9b18522ea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasonic Scaler Insert
• Version Model Number: DP10/25K
• Catalog Number: 508801
• Company DUNS: 600007124
• Company Name: DELDENT LTD.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	07290016281415 [Primary]

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

[07290016281415]

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: 2016-09-24

On-Brand Devices [Ultrasonic Scaler Insert]

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• 07290016281552: Magnetostrictive dental scaler insert
• 07290016281545: Magnetostrictive dental scaler insert
• 07290016281514: Magnetostrictive dental scaler insert
• 07290016281460: Magnetostrictive dental scaler insert
• 07290016281453: Magnetostrictive dental scaler insert
• 07290016281446: Magnetostrictive dental scaler insert
• 07290016281415: Magnetostrictive dental scaler insert
• 07290016281279: Magnetostrictive dental scaler insert
• 07290016281262: Magnetostrictive dental scaler insert
• 07290016281255: Magnetostrictive dental scaler insert
• 07290016281248: Magnetostrictive dental scaler insert
• 07290016281217: Magnetostrictive dental scaler insert
• 07290016281200: Magnetostrictive dental scaler insert
• 07290016281170: Magnetostrictive dental scaler insert
• 07290016281163: Magnetostrictive dental scaler insert
• 07290016281156: Magnetostrictive dental scaler insert
• 07290016281149: Magnetostrictive dental scaler insert
• 07290016281118: Magnetostrictive dental scaler insert
• 07290016281101: Magnetostrictive dental scaler insert