Delsonic 2000 Scaler 512200

GUDID 07290016281941

Dental scaler unit

DELDENT LTD.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 07290016281941
• NIH Device Record Key: c7298bac-6caf-4b6a-baeb-d941f10f744b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delsonic 2000 Scaler
• Version Model Number: 115 V
• Catalog Number: 512200
• 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: true
• 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	07290016281941 [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

[07290016281941]

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

Devices Manufactured by DELDENT LTD.

• 07290016281842 - JETSTREAM: 2023-06-15 Dental Airpolishing unit
• 07290016281026 - MB coupling Midwest: 2022-11-30 Coupling to Connect sandblaster to air supply provided by Midwest ( 4 hole ) dental unit tubing
• 07290016281033 - MB coupling Borden: 2022-11-30 Coupling to Connect sandblaster to air supply provided by Borden ( 2-3 hole ) dental unit tubing
• 07290016281040 - MB Quick coupling Kavo: 2022-11-30 Coupling to Connect sandblaster to air supply provided by Kavo dental unit tubing
• 07290016281057 - MB Quick coupling Sirona: 2022-11-30 Coupling to Connect sandblaster to air supply provided by Sirona dental unit tubing
• 07290016281064 - MB Quick coupling W&H: 2022-11-30 Coupling to Connect sandblaster to air supply provided by W&H dental unit tubing
• 07290016281835 - JETSTREAM POWDER: 2022-03-24 AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, FOR REMOVAL OF STAINS AND PLAQUE.
• 07290016281996 - JETSONIC 2000M HANDPIECE: 2018-10-18 Dental Scaler Handpiece