FDA.reportPublic FDA data

StarDental Instrument Solutions

Primary DI
D702RT3001130
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
RT3-00113
Device description
Patient Glasses (Yellow)
Published
2016-09-12
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
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D702RT3001130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
059010363
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7022666540StarDental2666542026-09-18
D7022666550StarDental2666552026-09-18
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440825No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440955No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440962No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
06977198050015DuyingTaizhou Duying GLASSES Co., Ltd.HQY2026-10-24
08800348923892Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923915Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923922Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923939Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923946Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
06973541158643REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158650REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158667REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
16973541158336SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
16973541158343SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158166SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158173SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158180SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158197SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158203SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158210SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158333SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158340SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
08800348923779Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923786Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923793Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923809Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923816Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923823Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923830Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20