Quolis 5000 Series Dental Unit AU-BDS5100

GUDID 04952195344505

BELMONT QUOLIS 5000 SERIES DENTAL UNIT

TAKARA-BELMONT CO., LTD.

Dental delivery system Dental delivery system Dental delivery system Dental delivery system
Primary Device ID04952195344505
NIH Device Record Keyfc202d48-7843-4830-acf4-33cd3f02f6da
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuolis 5000 Series Dental Unit
Version Model NumberQuolis
Catalog NumberAU-BDS5100
Company DUNS690540349
Company NameTAKARA-BELMONT CO., LTD.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732 4695000
Emailgstern@belmontequip.com
Phone732 4695000
Emailgstern@belmontequip.com
Phone732 4695000
Emailgstern@belmontequip.com
Phone732 4695000
Emailgstern@belmontequip.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104952195344505 [Primary]
GS104952195344505 [Primary]
GS104952195344505 [Primary]
GS104952195344505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRDUnit, Operative Dental, Accessories
NRDUnit, Operative Dental, Accessories
NRDUnit, Operative Dental, Accessories
NRDUnit, Operative Dental, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by TAKARA-BELMONT CO., LTD.

04952195078288 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195093557 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195195329 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195195343 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195196685 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195197866 - Bel-Halo LED2020-11-30 LIGHT, OPERATING, DENTAL
04952195217311 - Belmont X-Calibur Unit2020-11-30 Belmont X-Calibur Unit PMU WITH CUSPIDOR BOWL AND ASSISTANT
04952195217328 - Belmont X-Calibur Unit2020-11-30 Belmont X-Calibur Unit CMOP DOCTOR TABLE

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.