FDA.reportPublic FDA data

Quolis 5000 Series Dental Unit

Primary DI
04952195344505
Brand
Quolis 5000 Series Dental Unit
Company
TAKARA BELMONT CORP.
Model
Quolis
Catalog number
AU-BDS5100
Device description
BELMONT QUOLIS 5000 SERIES DENTAL UNIT
Published
2020-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072273000BELMONT QUOLIS 5000 SERIES DENTAL UNITTakara Belmont USA, Inc.2007-12-20NRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04952195344505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04952195344505049521953445054952195344505

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
732 4695000gstern@belmontequip.com

Regulatory Flags#

DUNS number
690540349
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04952195235728PHOT-X II, MODEL 303AR-33WKCNJ1AR-33WKCNJ12026-05-11
04952195347414PHOT-X II, MODEL 303AR-33WKCNJ3AR-33WKCNJ32026-05-11
04952195347421PHOT-X II, MODEL 303AR-33WKCNJ5AR-33WKCNJ52026-05-11
04952195347438PHOT-X II, MODEL 303AR-33WKCNJ8AR-33WKCNJ82026-05-11
04952195483259Evogue Dental UnitAU-HV3610AU-HV36102026-05-11
04952195462339Evogue Dental UnitAU-HV3420C-USAU-HV3420C-US2025-03-26
04952195372331Bel-Nova LEDBel-Nova LEDAL-D107G-NA-H2020-11-20
04952195436170DG-770-RSTAW-G091X2023-11-08
04952195354627DG-770-FAW-G090X2021-06-11
04952195406692Bel-Halo Dental LightAL-D241G-NAAL-D241G-NA2023-06-16
04952195406708Bel-Halo Dental LightAL-D241W-NAAL-D241W-NA2023-06-16
04952195406715Bel-Halo Dental LightAL-D242G-NAAL-D242G-NA2023-06-16
04952195406722Bel-Halo Dental LightAL-D245G-NA-HAL-D245G-NA-H2023-06-16
04952195406739Bel-Halo Dental LightAL-D246G-EVAL-D246G-EV2023-06-16
04952195406746Bel-Halo Dental LightAL-D246G-QUAL-D246G-QU2023-06-16
04952195406753Bel-Halo Dental LightAL-D247G-NAAL-D247G-NA2023-06-16
04952195406760Bel-Halo Dental LightAL-D248G-NA-HAL-D248G-NA-H2023-06-16
04952195406777Bel-Halo Dental LightAL-D249W-XAL-D249W-X2023-06-16
04952195406784Bel-Halo Dental LightAL-D249W-XNAL-D249W-XN2023-06-16
04952195408504Evogue Dental UnitAU-HV3401WAU-HV3401W2023-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08