Delsonic 2000 Scaler 512200

GUDID 07290016281941

Dental scaler unit

DELDENT LTD.

Ultrasonic dental scaling/debridement system
Primary Device ID07290016281941
NIH Device Record Keyc7298bac-6caf-4b6a-baeb-d941f10f744b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelsonic 2000 Scaler
Version Model Number115 V
Catalog Number512200
Company DUNS600007124
Company NameDELDENT LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016281941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290016281941]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by DELDENT LTD.

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07290016281040 - MB Quick coupling Kavo2022-11-30 Coupling to Connect sandblaster to air supply provided by Kavo dental unit tubing
07290016281057 - MB Quick coupling Sirona2022-11-30 Coupling to Connect sandblaster to air supply provided by Sirona dental unit tubing
07290016281064 - MB Quick coupling W&H2022-11-30 Coupling to Connect sandblaster to air supply provided by W&H dental unit tubing
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07290016281996 - JETSONIC 2000M HANDPIECE 2018-10-18 Dental Scaler Handpiece

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