AirLight M800X

GUDID 00628504370285

M800X-M/ST, STAR Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic
Primary Device ID00628504370285
NIH Device Record Keyecd09954-ec46-427a-8c83-482fd516036f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAirLight M800X
Version Model NumberHP3054X
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
GS100628504370285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628504370285]

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

On-Brand Devices [AirLight M800X]

00628504370339M800X-M/PD, Beyes PD Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
00628504370285M800X-M/ST, STAR Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
00628504370247M800X-M/N, NSK Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
00628504370216M800X-M/K, KaVo Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)

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