STRAIGHT SMILE LLC

Address:18120 S Broadway,Gardena,CA,90248,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Impression (ELW) (4) Tray, Impression, Preformed (EHY) (4) Instruments, Dental Hand (DZN) (2) Accessories, Retractor, Dental (EIF) (1) Heat Source For Bleaching Teeth (EEG) (1) Cleanser, Denture, Over The Counter (EFT) (1) Eraser, Dental Stain (MAU) (1)

Premarket Exempt

No Yes

Clear

Smile Stretcher - 00850017524002 Catalog Number :

Device Description : Device to retract the lips/cheeks to facilitate viewing of the teeth.

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 1

Impression Kit Standard - 00850017524019 Catalog Number :

Device Description : Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

Device Class : 2

Duns Number: 081010579

Premarket Exempt : No

Product Code : ELW, EHY

Prescription Use : Yes

Device Count : 1

Impression Rekit (Small) - 00850017524033 Catalog Number :

Device Description : Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

Device Class : 1

Duns Number: 081010579

Premarket Exempt : No

Product Code : ELW, EHY

Prescription Use : Yes

Device Count : 1

Impression Rekit (Medium) - 00850017524040 Catalog Number :

Device Description : Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

Device Class : 1

Duns Number: 081010579

Premarket Exempt : No

Product Code : ELW, EHY

Prescription Use : Yes

Device Count : 1

Impression Rekit (Large) - 00850017524057 Catalog Number :

Device Description : Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

Device Class : 1

Duns Number: 081010579

Premarket Exempt : No

Product Code : ELW, EHY

Prescription Use : Yes

Device Count : 1

BrightByte - 00850017524064 Catalog Number :

Device Description : A liquid cleansing agent used to remove small debris from plastic aligners

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : EFT

Prescription Use : No

Device Count : 1

Brightbyte Pro Whitening Kit - 00850017524088 Catalog Number :

Device Description : LED teeth whitening kit

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : EEG

Prescription Use : No

Device Count : 1

Brightbyte Pro Refill Pens - 00850017524118 Catalog Number :

Device Description : Whitening and Desensitizing Gel Pens

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : MAU

Prescription Use : No

Device Count : 1

Chewies - 00850017524132 Catalog Number :

Device Description : A tool to assist in seating aligners and retainers around teeth

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Retainer Retriever - 00850017524149 Catalog Number :

Device Description : A tool to remove aligners and retainers from around the teeth

Device Class : 1

Duns Number: 081010579

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

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