Perio-Control Tips

GUDID 04560264563780

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID04560264563780
NIH Device Record Key7a633c27-52cc-4436-a834-bb7660c3af4d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerio-Control Tips
Version Model NumberPerio-Control Tips Starter Kit
Company DUNS690710546
Company NameNAKANISHI INC.
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
GS104560264563780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264563780]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Perio-Control Tips]

04560264563780Perio-Control Tips Starter Kit
04560264563773Perio-Control Tips Starter Kit(V10-E Set)
04560264562356Perio-Control Tips Air Scaler Kit

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