FDA.reportPublic FDA data

OralID Over Glasses

Primary DI
00370275123705
Brand
OralID Over Glasses
Company
Forward Science Technologies LLC
Model
OralID Over Glasses 1ct
Device description
The OralID Over Glasses are designed as an accessory for use with the OralID device. These over glasses feature a filter that enhances the visualization capabilities of the OralID device, which is used for oral cancer screening. The filtered lenses are optimized to block specific wavelengths of light, enabling the observation of healthy and abnormal tissues when used in conjunction with the OralID device. These glasses are intended for use in dental and medical settings.
Published
2025-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

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
00370275123705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370275123705003702751237053702751237050370275123705

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-696-7254info@forwardscience.com

Regulatory Flags#

DUNS number
079212068
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370275900801PerioStomPremier 16ct90080002026-08-07
00370275090168PerioStomPerioStom 16ct2024-02-14
00370275123088OralID Fitted GlassesOralID Fitted 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
00370275629047SalivaMAXSalivaMAX 30ct – 04 NDC2024-02-14
00370275850106BioStomBioStom 1ct2024-02-14
00370275850250BioStomBioStom 25ct2024-02-14
00370275850502BioStomBioStom 10ct2024-02-14
00370275123163OralIDFS-112016-10-03
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
16973541157797SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158227SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158234SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158241SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158258SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158265SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158272SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158289SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158296SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158302SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228670Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14