FDA.report

SCHICK33

Primary DI
D764B11182000
Brand
SCHICK33
Company
SIRONA DENTAL, INC.
Model
B1118200
Device description
SCHICK33 S1 SENSOR
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications

CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D764B11182000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Sterilization Methods

Method

Contacts

PhoneEmail
(877) 724-4254customerserviceny@sirona.com

Regulatory Flags

DUNS number
078613913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
D764B10731071Universal HoldersB10731072022-12-07
D764B10731081Universal HoldersB10731082022-12-07
D764B10731531Intraoral Sensor HolderB10731532022-12-07
D764B10731551Intraoral Sensor HolderB10731552022-12-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800018408209EXPD 4343SDRTECH CorporationMQB2026-03-17
08800018408308EXPD 4343DDRTECH CorporationMQB2026-03-17
08800018408407EXPD 3643DDRTECH CorporationMQB2026-03-17
04549292223774CANON INC.CANON INC.MQB2026-02-06
00854344007795Varex Digital Imaging Software, Nexus DR, v4.19VAREX IMAGING CORPORATIONMQB2026-01-16
04719879300130YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300147YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300154YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300161YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
08800069500105BONX805, DIONE-X80 Portable X-ray Imaging Devicebontech IncMQB2025-12-03
00854344007771Varex Digital Imaging Software, Nexus DR, v4.18VAREX IMAGING CORPORATIONMQB2025-11-13
08800069500013BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500020BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500037BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500044BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500051BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500068BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
04547410484786FDR D-EVO III G35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484793FDR D-EVO III G43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484809FDR D-EVO III C35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484816FDR D-EVO III C43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484823FDR D-EVO III C25iFUJIFILM CORPORATIONMQB2025-08-29
04547410511673FDR D-EVO III G80iFUJIFILM CORPORATIONMQB2025-08-29
04547410515176DR-ID 1200MCFUJIFILM CORPORATIONMQB2025-08-29
08800018430002EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430101EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430200EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430309EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430408EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430507EXPD-N seriesDRTECH CorporationMQB2025-06-13