JETSONIC 2000M HANDPIECE 533002

GUDID 07290016281996

Dental Scaler Handpiece

DELDENT LTD.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 07290016281996
• NIH Device Record Key: bda7f1f0-6a90-40bf-a326-d5ee029eb940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETSONIC 2000M HANDPIECE
• Version Model Number: 533002
• Catalog Number: 533002
• 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	07290016281996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014245

FDA Product Code

• KOJ: Airbrush

Sterilization

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

[07290016281996]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-18
• Device Publish Date: 2018-09-17

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: 2018-10-18Dental Scaler Handpiece
• 07290016281996 - JETSONIC 2000M HANDPIECE: 2018-10-18 Dental Scaler Handpiece