FDA.reportPublic FDA data

Brightbyte Pro Refill Pens

Primary DI
00850017524118
Brand
Brightbyte Pro Refill Pens
Company
STRAIGHT SMILE LLC
Model
BBPRP
Device description
Whitening and Desensitizing Gel Pens
Published
2022-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MAUEraser, Dental Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAUEraser, Dental StainDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017524118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017524118008500175241188500175241180850017524118

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-765-2327support@byteme.com

Regulatory Flags#

DUNS number
081010579
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017524224Portable UV SanitizerBYTEUVS2023-03-20
00850017524163Byte Day AlignesHBYTETrayPRS-00632022-05-31
00850017524170Byte Night AlignersNBYTETrayPRS-00632022-05-31
00850017524187Byte RetainerBYTERetainerTrayPRS-00632022-05-31
00850017524200Brightbyte Pro (wireless) Whitening KitBYTEBBP22023-09-07
00850017524132ChewiesBCHW22022-06-02
00850017524064BrightBytebb2022-09-30
00850017524088Brightbyte Pro Whitening KitBYTEBBP2022-06-06
00850017524002Smile StretcherBSS12022-06-02
00850017524019Impression Kit StandardKIT2022-06-02
00850017524033Impression Rekit (Small)BYTERKS2022-06-02
00850017524040Impression Rekit (Medium)BYTERKM2022-06-02
00850017524057Impression Rekit (Large) BYTERKL2022-06-02
00850017524149Retainer RetrieverBRR12022-06-02
00860000506007Byte Aligner SystemPRS-0063PRS-00632019-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825523SmileDirectClub Dissolving StripsOrtho Dental Lab LLCMAU2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 PackOrtho Dental Lab LLCMAU2025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 PackOrtho Dental Lab LLCMAU2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCMAU2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCMAU2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCMAU2025-09-25
00850078989154SmileSet Premium Whitening Refill – 4 PackOrtho Dental Lab LLCMAU2025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 mlOrtho Dental Lab LLCMAU2025-09-25
00850078989178SmileSet Premium Sensitive Whitening StripsOrtho Dental Lab LLCMAU2025-09-25
00353238006208Perio Sciences LED Tooth WhitenerPerio Sciences, LLCMAU2024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening PensPerio Sciences, LLCMAU2024-02-08
06970016621824NonJiangxi Dentalbright Technology Co., LtdMAU2023-05-06
07506338301480MDC DentalMDC DENTALMAU2023-05-04
06970016623651DanielJiangxi Dentalbright Technology Co., LtdMAU2023-03-25
06970016621404GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621534GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621831GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621879GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622005GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622807GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622920GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623057GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623200GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623293GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624030GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624481GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624887GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625006GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22