NUSMILE, LTD.

Address:3315 W 12th St,HOUSTON,TX,77008,US

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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

Crown, Preformed (ELZ) (10)

Premarket Exempt

Yes No

Clear

NuSmile Signature Anterior Replacement Crown - 00850008515705 Catalog Number :

Device Description : NuSmile Signature Anterior Replacement Crown - Lateral, Size 3 - Regular Length NuSmile Signature Anterior Replacement Crown - Lateral, Size 3 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Anterior Replacement Crown - 00850008515712 Catalog Number :

Device Description : NuSmile Signature Anterior Replacement Crown - Lateral, Size 4 - Regular Length NuSmile Signature Anterior Replacement Crown - Lateral, Size 4 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Anterior Replacement Crown - 00850008515729 Catalog Number :

Device Description : NuSmile Signature Anterior Replacement Crown - Lateral, Size 5 - Regular Length NuSmile Signature Anterior Replacement Crown - Lateral, Size 5 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Anterior Replacement Crown - 00850008515736 Catalog Number :

Device Description : NuSmile Signature Anterior Replacement Crown - Lateral, Size 6 - Regular Length NuSmile Signature Anterior Replacement Crown - Lateral, Size 6 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515743 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 1 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 1 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515750 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 0 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 0 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515767 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 3 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 3 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515774 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 2 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 2 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515781 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 4 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 4 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

NuSmile Signature Cuspid Replacement Crown - 00850008515798 Catalog Number :

Device Description : NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 5 - Regular Length / E NuSmile Signature Cuspid Replacement Crown - Cuspid, Size 5 - Regular Length / Extra Light Shade

Device Class : 1

Duns Number: 185497372

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

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