Maxso M200E

GUDID 00628504370155

M200E-M/M4, M4 Backend, Single Spray, Non-Optic

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic
Primary Device ID00628504370155
NIH Device Record Keyf74fc8e7-812a-437f-80e1-52bae4d46e75
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxso M200E
Version Model NumberHP2105
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
GS100628504370155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628504370155]

Moist Heat or Steam Sterilization


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

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
00990010306677 - Comfort-Sonic 2024-01-29 Woodpecker: PC1 , Sickle scaler type for removal of supragingival calculus. The diamond-shaped cross-section allows efficient sc
00990010306684 - Comfort-Sonic 2024-01-29 Woodpecker: GK5, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; for the a
00990010306691 - Comfort-Sonic 2024-01-29 Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from firs
00990010306707 - Comfort-Sonic 2024-01-29 Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in pockets up to 9 mm deep; from sec
00990010306714 - Comfort-Sonic 2024-01-29 Woodpecker: GK11 , For orthodontic
00990010306721 - Comfort-Sonic 2024-01-29 Woodpecker: EK8, For root canal enlargement and cleaning

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