FDA.reportPublic FDA data

Tuxedo

Primary DI
00754020100249
Brand
Tuxedo
Company
LED Dental Inc
Model
Size 2 Replacement (A-Series)
Catalog number
6101AR
Device description
Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00754020100249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754020100249007540201002497540201002490754020100249

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
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 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
07540201000063TuxedoSize 16100, 6100A2016-09-24
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
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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08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
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D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06