Comfort-Sonic K-51

GUDID 00990010306738

Woodpecker: GK20 , for “supragingival shoulder” preparation after the completion of the preparation

Beyes Dental Canada Inc

Ultrasonic dental scaling/debridement system
Primary Device ID00990010306738
NIH Device Record Key832cdbee-3928-47ef-875d-15ac19fa56db
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort-Sonic
Version Model NumberUL2222
Catalog NumberK-51
Company DUNS244261462
Company NameBeyes Dental Canada Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100990010306738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


[00990010306738]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-29
Device Publish Date2024-01-19

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.