Comfort-Sonic

GUDID 00837699000840

COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE

Beyes Dental Canada Inc

Ultrasonic dental scaling/debridement system
Primary Device ID00837699000840
NIH Device Record Keya55348cd-4213-4cc4-91cf-d651593867b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort-Sonic
Version Model NumberUL3300
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100837699000840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


[00837699000840]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-14
Device Publish Date2022-10-06

On-Brand Devices [Comfort-Sonic ]

00837699000833Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1)
00837699000826Comfort-Sonic LED Scalers P9, includes 8 tips ( EE1, EG1, EG4, EG5, EG6, EP1, EP3, EP4D), 1 tip
00837699000840COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE
00990010302037COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE
00990010302020Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1)
00990010302013Comfort-Sonic LED Scalers P9, includes 8 tips ( EE1, EG1, EG4, EG5, EG6, EP1, EP3, EP4D), 1 tip
00990010306646Woodpecker: GK4 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p
00990010306639Woodpecker: GK3, For removal of large areas of supragingival calculus
00990010306622Woodpecker: GK2 , For removal of large areas of supragingival calculus
00990010306615Woodpecker: GK1, For removal of large areas of calculus
00990010306738Woodpecker: GK20 , for “supragingival shoulder” preparation after the completion of the prep
00990010306721Woodpecker: EK8, For root canal enlargement and cleaning
00990010306714Woodpecker: GK11 , For orthodontic
00990010306707Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p
00990010306691Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in po
00990010306684Woodpecker: GK5, Gentle pocket cleansing during periodontal treatment; effective cleansing in po
00990010306677Woodpecker: PC1 , Sickle scaler type for removal of supragingival calculus. The diamond-shaped c
00990010306660Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the nec
00990010306653Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical t

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