FDA.reportPublic FDA data

VELscope

Primary DI
00754020100010
Brand
VELscope
Company
LED Dental Inc
Model
VELscope Vx
Catalog number
4200-1
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NXVDiagnostic Light, Soft Tissue Detector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXVDiagnostic Light, Soft Tissue DetectorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102083000VELSCOPE VXLed Dental, Inc.2010-11-18NXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00754020100010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754020100010007540201000107540201000100754020100010

GMDN Terms#

Term, Definition table
TermDefinition
Oral lesion examination lightA battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device.

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
00754020100249Tuxedo Size 2 Replacement (A-Series)6101AR2019-06-21
00754020100041VELscopeVELscope Vx Value Bundle-US46622016-09-24
00754020100096VELscopeVELscope Vx Value Bundle-Basic46602016-12-21
00754020100065TuxedoSize 161002016-09-24
00754020100072TuxedoSize 22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8136501180ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10030ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10050ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10080ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
00860179001075FUSION-DOE Light SystemDentlight Inc.NXV2021-08-09
D86911009002AdDentADDENT, INC.NXV2017-06-01
D8691120010AdDentADDENT, INC.NXV2017-06-01
07540201000094VELscopeLED Dental IncNXV2016-12-21
00754020100096VELscopeLED Dental IncNXV2016-12-21
D813PLS10010VIZILITE PRO DEN-MAT HOLDINGS, LLCNXV2016-11-14
08051040582003G.o.c.c.l.e.s.PIERREL SPANXV2016-10-21
08051040582010G.o.c.c.l.e.s. lightPIERREL SPANXV2016-10-21
00370275123163OralIDForward Science Technologies LLCNXV2016-10-03
07540201000032VELscopeLED Dental IncNXV2016-09-24
07540201000025VELscopeLED Dental IncNXV2016-09-24
27540201000036VELscopeLED Dental IncNXV2016-09-24
07540201000049VELscopeLED Dental IncNXV2016-09-24
00754020100041VELscopeLED Dental IncNXV2016-09-24
D8136501010 ViziLite®DEN-MAT HOLDINGS, LLCNXV2016-09-24
D702RT3003900StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-15
D702RT3001050StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003710StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003720StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003860StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003870StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
07540201000018VELscopeLED Dental IncNXV2016-08-22