FDA.reportPublic FDA data

Portable UV Sanitizer

Primary DI
00850017524224
Brand
Portable UV Sanitizer
Company
STRAIGHT SMILE LLC
Model
BYTEUVS
Device description
Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)
Published
2023-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017524224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017524224008500175242248500175242240850017524224

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet device microbial reduction unitA portable electrically-powered device intended to reduce microbial and organic soil loads on the surface of noninvasive medical equipment, and other non-porous contact surfaces, using ultraviolet C (UVC) light; it is not intended for device disinfection. It includes UVC lights and controls and is intended to be placed in proximity to the devices to be decontaminated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081010579
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850017524118Brightbyte Pro Refill PensBBPRP2022-06-06
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
00850078989017SmileSet QX105 Ultrasonic Cleaner - BlackOrtho Dental Lab LLCNOB2025-09-17
00850078989031SmileSet QX105 Ultrasonic Cleaner - MintOrtho Dental Lab LLCNOB2025-09-17
00850078989048SmileSet QX105 Ultrasonic Cleaner - WhiteOrtho Dental Lab LLCNOB2025-09-17
00850078989055SmileSet Rechargeable Ultrasonic Cleaner - BlackOrtho Dental Lab LLCNOB2025-09-17
00850078989062Smileset Rechargeable Ultrasonic Cleaner – MintOrtho Dental Lab LLCNOB2025-09-17
00850078989079Smileset Rechargeable Ultrasonic Cleaner – WhiteOrtho Dental Lab LLCNOB2025-09-17
00816063021896Invisalign UV Sanitizing CaseAlign Technology, Inc.NOB2023-07-24
00840326408230The Orthodontic StoreYoung Innovations, Inc.NOB2022-11-24
00075020095770Philips SonicarePHILIPS ORAL HEALTHCARE, LLCNOB2020-09-24