FDA.reportPublic FDA data

Vanguard

Primary DI
ERICVSP000110
Brand
Vanguard
Company
Ritter Concept GmbH
Model
VSP000110
Published
2022-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental
KLCChair, Dental, With Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1
KLCChair, Dental, With Operative UnitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161734000Vanguard Dental UnitRitter Concept GmbH2016-12-09EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERICVSP000110PrimaryHIBCC0

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
1-855-807-8111info@ritterdentalusa.com

Regulatory Flags#

DUNS number
330153086
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ERICCLC000110Contact Lite ComfortCLC0001102024-07-30
ERICCW0000110Contact WorldCW00001102024-07-30
ERICUC0000110Ultimate ComfortUC00001102024-07-30
ERICUCS000110Ultimate Comfort SmartUCS0001102024-07-30
ERICUCSP00110Ultimate Comfort Smart PUCSP001102024-07-30
ERICEH500000Excom hybridExcom hybrid 52024-02-12
ERICRA72D000RARA 7/2 D2024-02-12
ERICRA73D000RARA 7/3 D2024-02-12
ERICRA74D000RARA 7/4 D2024-02-12
ERICV00000110VanguardV000001102022-08-17
ERICVP0000110VanguardVP00001102022-08-17
ERICVS0000110VanguardVS00001102022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08
10817417021538AsepticoASEPTICO, INC.EIA2022-12-08
10817417021545AsepticoASEPTICO, INC.EIA2022-12-08
10817417021552AsepticoASEPTICO, INC.EIA2022-12-08
10817417021569AsepticoASEPTICO, INC.EIA2022-12-08
10817417021576AsepticoASEPTICO, INC.EIA2022-12-08
10817417021583AsepticoASEPTICO, INC.EIA2022-12-08
10817417021590AsepticoASEPTICO, INC.EIA2022-12-08
10817417021606AsepticoASEPTICO, INC.EIA2022-12-08