FDA.reportPublic FDA data

SCHICK ELITE

Primary DI
D764B22501501
Brand
SCHICK ELITE
Company
SIRONA DENTAL, INC.
Model
B2250150
Device description
USB REMOTE HS / ELITE CABLE (5 METER)
Published
2016-09-09
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
EHDUnit, X-Ray, Extraoral With Timer
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072134000SCHICK COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.2007-11-02MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D764B22501501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device USB cableAn insulated metal wire(s) intended to be used to standardize the connection between an electronic medical device and a computer for communication and/or power supply.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 724-4254customerserviceny@sirona.com

Regulatory Flags#

DUNS number
078613913
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7641000087211Schick331000087212022-03-23
D764B10742011AimRight HolderB10742012022-12-07
D764B10741041AimRight HolderB10741042022-12-07
D7641000086661Schick AE1000086662022-03-23
D7641000053241AimRight1000053242022-12-07
D7641000053251AimRight1000053252022-12-07
D7641000053301AimRight1000053302022-12-07
D7641000053311AimRight1000053312022-12-07
D7641000053321AimRight1000053322022-12-07
D7641000053331AimRight1000053332022-12-07
D7641000053341AimRight1000053342022-12-07
D7641000053451AimRight1000053452022-12-07
D764B02100001Intraoral Sensor Holders Arms and Rings B02100002022-12-07
D764B10730621Universal HoldersB10730622022-12-07
D764B10731001Intraoral Sensor Holder Arms and RingsB10731002022-12-07
D764B10731011Universal HoldersB10731012022-12-07
D764B10731021Universal HoldersB10731022022-12-07
D764B10731031Universal HoldersB10731032022-12-07
D764B10731041Universal HoldersB10731042022-12-07
D764B10731061Universal HoldersB10731062022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
08800003027019RAYSCANRay Co., LtdMUH2025-08-25
08800003027033RAYSCANRay Co., LtdMUH2025-08-25
08800003027040RAYSCANRay Co., LtdMUH2025-08-25
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
088000186021950909FCCRayence Co., Ltd.MQB2024-03-21
088000186022010909FCC-HSRayence Co., Ltd.MQB2024-03-21
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18