FDA.reportPublic FDA data

OralID

Primary DI
00370275123163
Brand
OralID
Company
Forward Science Technologies LLC
Model
FS-11
Device description
OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
Published
2016-10-03
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
K123169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123169000ORALIDForward Science, LLC2013-03-13NXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00370275123163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370275123163003702751231633702751231630370275123163

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
855-696-7254info@forwardscience.com

Regulatory Flags#

DUNS number
079212068
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370275123088OralID Fitted GlassesOralID Fitted Glasses 1ct2025-01-22
00370275123705OralID Over GlassesOralID Over Glasses 1ct2025-01-22
00370275092025FS Dispenser, StainlessStainless FS Dispenser 1ct2024-10-14
00370275091011FS DispenserFS Dispenser 1ct2024-02-21
00370275713050OrapeuticOrapeutic 5ct2024-02-14
00037027571305OrapeuticOrapeutic 5ct2024-02-14
00370275090168PerioStomPerioStom 16ct2024-02-14
00370275629047SalivaMAXSalivaMAX 30ct – 04 NDC2024-02-14
00370275850106BioStomBioStom 1ct2024-02-14
00370275850250BioStomBioStom 25ct2024-02-14
00370275850502BioStomBioStom 10ct2024-02-14
00370275629030SalivaMAXSalivaMAX 30ct2016-10-03
00370275629122SalivaMAXSalivaMAX 120Ct2016-10-03
00370275629306SalivaMAXSalivaMAX 300Ct2016-10-03

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
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