FDA.reportPublic FDA data

Tuxedo

Primary DI
07540201000063
Brand
Tuxedo
Company
LED Dental Inc
Model
Size 1
Catalog number
6100, 6100A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153710000Tuxedo Digital Dental SensorLed Dental, Inc.2016-03-18MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540201000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540201000063075402010000637540201000063

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

Regulatory Flags#

DUNS number
243167546
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540201000025VELscopeVELcap Vx57102016-09-24
07540201000049VELscopeVELscope Vx Value Bundle-US46622016-09-24
07540201000094VELscopeVELscope Vx Value Bundle-Basic46602016-12-21
07540201000032VELscopeVELsheath Vx57202016-09-24
07540201000018VELscopeVELscope Vx4200-12016-08-22
27540201000036VELscopeVELsheath Vx57202016-09-24
07540201000070TuxedoSize 26101, 6101A2016-09-24
07540201000216Tuxedo Size 1 Replacement 6100R2019-06-21
07540201000223Tuxedo Size 2 Replacement 6101R2019-06-21
07540201000230Tuxedo Size 1 Replacement (A-Series)6100AR2019-06-21
07540201000247Tuxedo Size 2 Replacement (A-Series)6101AR2019-06-21
00754020100218Tuxedo Size 1 Replacement 6100R2019-06-21
00754020100225Tuxedo Size 2 Replacement 6101R2019-06-21
00754020100232Tuxedo Size 1 Replacement (A-Series)6100AR2019-06-21
00754020100249Tuxedo Size 2 Replacement (A-Series)6101AR2019-06-21
00754020100041VELscopeVELscope Vx Value Bundle-US46622016-09-24
00754020100096VELscopeVELscope Vx Value Bundle-Basic46602016-12-21
00754020100010VELscopeVELscope Vx4200-12016-08-22
00754020100065TuxedoSize 161002016-09-24
00754020100072TuxedoSize 22016-09-24

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Primary DI, Brand, Company table
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08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
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08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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D0031000086520SchickDentsply International Inc.MQB2024-11-06