Ultrasonic Scaler Insert 508806

GUDID 07290016281460

Magnetostrictive dental scaler insert

DELDENT LTD.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID07290016281460
NIH Device Record Keyf7f3e1c2-01a5-4f09-9cf0-9318b32c374a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasonic Scaler Insert
Version Model NumberDP100/25K L
Catalog Number508806
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
GS107290016281460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290016281460]

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

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07290016281453Magnetostrictive dental scaler insert
07290016281446Magnetostrictive dental scaler insert
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07290016281262Magnetostrictive dental scaler insert
07290016281255Magnetostrictive dental scaler insert
07290016281248Magnetostrictive dental scaler insert
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07290016281200Magnetostrictive dental scaler insert
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07290016281149Magnetostrictive dental scaler insert
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07290016281101Magnetostrictive dental scaler insert

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