FDA.reportPublic FDA data

FUSION-DOE Light System

Primary DI
00860179001075
Brand
FUSION-DOE Light System
Company
Dentlight Inc.
Model
7700512
Catalog number
7700512
Device description
FUSION-DOE Light System
Published
2021-08-09
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101140000DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.2010-07-15NXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860179001075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860179001075008601790010758601790010750860179001075

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007636901sales1@dentlight.com

Regulatory Flags#

DUNS number
171208585
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860179001013FUSION PBM Plus Light792008079200802026-05-27
00860179001020Nano Freedom Headlight860011586001152021-08-09
00860179001044Ultrafast Diode Laser730010073001002022-01-24
00860179001006FUSION Curing Light780008078000802021-08-09
00860179001037FUSION Plus Curing Light782008078200802021-08-09
00860179001068FUSION Grand Curing Light783008078300802021-08-09
00860179001099iZoom Loupes850005185000512021-08-09

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
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
00754020100010VELscopeLED Dental IncNXV2016-08-22