ORTHO TECHNOLOGY, INC.

Address:1 Southern Ct.,West Columbia,SC,29169,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

MIRROR, MOUTH (EAX) (10)

Premarket Exempt

No Yes

Clear

PixSure Perfect® - 00190730088970 Catalog Number :

Device Description : Photo Mirror Lingual

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088987 Catalog Number :

Device Description : Photo Mirror Buccal Narrow

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088994 Catalog Number :

Device Description : Photo Mirror Buccal

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089007 Catalog Number :

Device Description : Adult/Child Occlusal-Round Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089014 Catalog Number :

Device Description : Buccal Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089021 Catalog Number :

Device Description : Adult/Child Occlusal-Square Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089038 Catalog Number :

Device Description : Adult Occlusal/Adult Buccal Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089045 Catalog Number :

Device Description : Lingual upper/Lingual Lower Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089052 Catalog Number :

Device Description : Adult Buccal/Child Buccal Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730089069 Catalog Number :

Device Description : Child Occlusal/Child Buccal Photographic Metal Mirror

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

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