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

TRAY, IMPRESSION, PREFORMED (EHY) (6) MIRROR, MOUTH (EAX) (4)

Premarket Exempt

No Yes

Clear

DuraLock® PLUS - 00190730088871 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS MEDIUM UPPER-GREEN 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

DuraLock® PLUS - 00190730088888 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS MEDIUM LOWER-GREEN 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

DuraLock® PLUS - 00190730088895 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS LARGE UPPER-YELLOW 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

DuraLock® PLUS - 00190730088901 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS LARGE LOWER-YELLOW 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

DuraLock® PLUS - 00190730088918 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS EXTRA LARGE UPPER-PURPLE 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

DuraLock® PLUS - 00190730088925 Catalog Number :

Device Description : DuraLock® PLUS IMPRESSION TRAYS EXTRA LARGE LOWER-PURPLE 50PK

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088932 Catalog Number :

Device Description : Photo Mirror Occlusal Child

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088949 Catalog Number :

Device Description : Photo Mirror Occlusal Child Extra Long

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088956 Catalog Number :

Device Description : Photo Mirror Occlusal Adult

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

PixSure Perfect® - 00190730088963 Catalog Number :

Device Description : Photo Mirror Occlusal Adult Extra Long

Device Class : 1

Duns Number: 781772017

Premarket Exempt : Yes

Product Code : EAX

Prescription Use : Yes

Device Count : 1

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