FDA.reportPublic FDA data

StarDental Instrument Solutions

Primary DI
D702RT3003720
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
RT3-00372
Device description
Identafi System International
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXVDiagnostic Light, Soft Tissue Detector

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D702RT3003720PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags#

DUNS number
059010363
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7022666500StarDental2666502666502026-04-22
D7022666510StarDental2666512666512026-04-22
D7022666520StarDental2666522666522026-04-22
D7022666530StarDental2666532666532026-04-22
D7022663420StarDental2663422663422025-06-20
D7022663430StarDental2663432025-06-20
D7022663450StarDental2663452025-06-20
D7022664900StarDental2664902025-06-20
D7022601520StarDental Instrument Solutions2601522018-11-05
D702RT3001050StarDental Instrument SolutionsRT3-001052016-09-13
D7022656330StarDental Instrument Solutions2656332018-11-05
D7022639480StarDental Instrument Solutions2639482018-11-05
D7022658060StarDental Instrument Solutions2658062018-11-05
D702RT3001130StarDental Instrument SolutionsRT3-001132016-09-12
D702RT3220000StarDental Instrument SolutionsRT3-220002016-09-12
D7022688600StarDental Instrument Solutions2688602018-11-05
D7022656300StarDental Instrument Solutions2656302018-11-05
D7022656340StarDental Instrument Solutions2656342018-11-05
D7022658210StarDental Instrument Solutions2658212018-11-05
D7022658220StarDental Instrument Solutions2658222018-11-05

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
D702RT3003860StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003870StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
07540201000018VELscopeLED Dental IncNXV2016-08-22
00754020100010VELscopeLED Dental IncNXV2016-08-22