ORAMETRIX, INC.

ORAMETRIX, INC.

Address:339 EAST AVE K-8, SUITE 117,LANCASTER,CA,93535,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

Aligner, Sequential (NXC) (6) Unit, Operative Dental (EIA) (2) Wire, Orthodontic (DZC) (2)

Premarket Exempt

No Yes

Clear

sureclear aligner - 00856379007009 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

sureclear template - 00856379007016 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

SureSmile aligner - 00856379007023 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

SureSmile attachment template - 00856379007030 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

SureSmile attachment template - 00856379007047 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

SureSmile Aligner Software - 00856379007085 Catalog Number :

Device Class : 2

Duns Number: 053101262

Premarket Exempt : No

Product Code : NXC

Prescription Use : No

Device Count : 1

SureSmile Ortho Software - 00856379007092 Catalog Number :

Device Class : 1

Duns Number: 053101262

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

SureSmile Advanced Software - 00856379007108 Catalog Number :

Device Class : 1

Duns Number: 053101262

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

SureSmile® - 00856379007122 Catalog Number : ASSY-000108

Device Description : Arch wire 16round CUNITI-NITI

Device Class : 1

Duns Number: 053101262

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

SureSmile® - 00856379007139 Catalog Number : ASSY-000109

Device Description : Arch wire 16x22 CUNITI-NITI

Device Class : 1

Duns Number: 053101262

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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