Evogue Dental Unit AU-HV3420C-US

GUDID 04952195462339

Evogue Dental Unit LEFT-RIGHT CUSPIDOR

TAKARA BELMONT CORP.

Dental delivery system
Primary Device ID04952195462339
NIH Device Record Key0e760daa-ab2e-49f3-8a2d-68c84df10391
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvogue Dental Unit
Version Model NumberAU-HV3420C-US
Catalog NumberAU-HV3420C-US
Company DUNS690540349
Company NameTAKARA BELMONT CORP.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com
Phone732 4695000
Emailgstern@belmonteqip.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104952195462339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

Devices Manufactured by TAKARA BELMONT CORP.

04952195462339 - Evogue Dental Unit2025-04-03Evogue Dental Unit LEFT-RIGHT CUSPIDOR
04952195462339 - Evogue Dental Unit2025-04-03 Evogue Dental Unit LEFT-RIGHT CUSPIDOR
04952195436170 - DG-770-RST2023-11-16

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