FDA.reportPublic FDA data

SCHICK ELITE

Primary DI
D764B12091201
Brand
SCHICK ELITE
Company
SIRONA DENTAL, INC.
Model
B1209120
Device description
SCHICK REPLACEABLE CABLE KIT 6FT
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D764B12091201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078613913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
06970569090856Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
D178XR3800Flight Dental SystemsFlight Dental Systems USA Inc.MUH2025-08-29
08800003027088RAYSCAN α-PRay Co., LtdMUH2025-08-25
03760262650814Owandy RadiologyOWANDY RADIOLOGYMUH2025-05-15
D804W13000050U-SENSE HDDE GÖTZEN SRLMUH2025-05-15
08809244060199GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060229GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060236GenorayGENORAY CO., LTD.MUH2025-05-02
00304040190623Henry ScheinHENRY SCHEIN, INC.MUH2025-03-05
06941877815196EighteethChangzhou Sifary Medical Technology Co., Ltd.MUH2025-01-21
08033837936817myrayCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936848NewTomCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936855CastelliniCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08800016401950VistaPano S 2.0VATECH CO., LTD.MUH2024-12-13
08800016401967VistaPano S Ceph 2.0VATECH CO., LTD.MUH2024-12-13
D9021050013MISTER X RAYDental Savings Club IncMUH2024-12-12
03760262651606I-MAXOWANDY RADIOLOGYMUH2024-11-11
D804W1200001FL0X-MIND primeDE GÖTZEN SRLMUH2024-11-11