Delsonic Scaler Insert 512053

GUDID 07290016281934

Dental scaler insert

DELDENT LTD.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 07290016281934
• NIH Device Record Key: 09ebf462-cc42-468a-83e4-738bc50db0a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delsonic Scaler Insert
• Version Model Number: No 3 Flat Horizontal
• Catalog Number: 512053
• 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	07290016281934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014238

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[07290016281934]

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 [Delsonic Scaler Insert]

• 07290016281934: Dental scaler insert
• 07290016281927: Dental scaler insert
• 07290016281910: Dental scaler insert
• 07290016281903: Dental scaler insert