StatClean Ultrasonic Cleaner SC-P4862

GUDID 07640397422042

Ultrasonic Cleaner

Dent4You AG

Ultrasonic-cleaning water bath
Primary Device ID07640397422042
NIH Device Record Keya8953a2e-c05c-4b16-b958-f762885962f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatClean Ultrasonic Cleaner
Version Model NumberSC-P4862
Catalog NumberSC-P4862
Company DUNS480152811
Company NameDent4You AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS107640397422042 [Primary]

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-19
Device Publish Date2026-03-11

Devices Manufactured by Dent4You AG

07640397422042 - StatClean Ultrasonic Cleaner2026-03-19Ultrasonic Cleaner
07640397422042 - StatClean Ultrasonic Cleaner2026-03-19 Ultrasonic Cleaner
07640397422189 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer
17640397422339 - HIP Cleaning Solution2026-02-19 Hydrim Cleaning Solution with Instrument Protection. For the Hydrim 112W G4+ Instrument Washer.
07640397422349 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer (Loaner)
07640397422356 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer (Refurbished)
07630243600595 - BRILLIANT Crios2026-02-18 BRILLIANT Crios Bleach LT 14 CEREC
07630243600601 - BRILLIANT Crios2026-02-18 BRILLIANT Crios A1 LT 14 CEREC
07630243600618 - BRILLIANT Crios2026-02-18 BRILLIANT Crios A2 LT 14 CEREC

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.