Byte Aligner System PRS-0063

GUDID 00860000506007

Sequential Aligners

STRAIGHT SMILE LLC

Orthodontic appliance system, progressive
Primary Device ID00860000506007
NIH Device Record Key13e5d939-1dc5-4dfb-a06d-d28f54f4fc6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameByte Aligner System
Version Model NumberPRS-0063
Catalog NumberPRS-0063
Company DUNS081010579
Company NameSTRAIGHT SMILE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000506007 [Primary]

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-20

Devices Manufactured by STRAIGHT SMILE LLC

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00850017524064 - BrightByte2022-10-10 A liquid cleansing agent used to remove small debris from plastic aligners
00850017524088 - Brightbyte Pro Whitening Kit2022-06-14 LED teeth whitening kit
00850017524118 - Brightbyte Pro Refill Pens2022-06-14 Whitening and Desensitizing Gel Pens
00850017524002 - Smile Stretcher2022-06-10 Device to retract the lips/cheeks to facilitate viewing of the teeth.
00850017524019 - Impression Kit Standard2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
00850017524033 - Impression Rekit (Small)2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

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