Delsonic Scaler Insert 512052

GUDID 07290016281927

Dental scaler insert

DELDENT LTD.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID07290016281927
NIH Device Record Key505b90eb-9d37-46ae-9eef-c52b93915a80
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelsonic Scaler Insert
Version Model NumberNo 2 Universal round
Catalog Number512052
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 Numberfalse
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
GS107290016281927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290016281927]

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

On-Brand Devices [Delsonic Scaler Insert]

07290016281934Dental scaler insert
07290016281927Dental scaler insert
07290016281910Dental scaler insert
07290016281903Dental scaler insert

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