Comfort-Sonic P6 Plus

GUDID 00628504370742

Ultrasonic Scaler, Direct-LED, Includes 6 Tips, 110V

Beyes Dental Canada Inc

Rotary dental scaler
Primary Device ID00628504370742
NIH Device Record Keyc95fa44d-eb7e-4783-97d9-1f46a7f62c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort-Sonic P6 Plus
Version Model NumberUL2104
Company DUNS244261462
Company NameBeyes Dental Canada 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628504370742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

Devices Manufactured by Beyes Dental Canada Inc

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00990010312586 - DURAY2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM
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00990010306653 - Comfort-Sonic 2024-01-29 Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical thirds of large and straight cana
00990010306660 - Comfort-Sonic 2024-01-29 Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the neck of the teeth

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