Medcad

Address:3401 Technology Dr,Plano,TX,75074,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

Driver, Wire, And Bone Drill, Manual (DZJ) (10) System, Image Processing, Radiological (LLZ) (10)

Premarket Exempt

Clear

AccuPlan® System - 00810007630687 Catalog Number : ZB-K003

Device Description : ORTHOGNATHIC, 3D PRINTED DENTAL MODELS

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630694 Catalog Number : ZB-K004

Device Description : ORTHOGNATHIC, SURGICAL GUIDE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630700 Catalog Number : ZB-K010

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630717 Catalog Number : ZB-K010-R

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630724 Catalog Number : ZB-K011

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL GUIDE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630731 Catalog Number : ZB-K020

Device Description : MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630748 Catalog Number : ZB-K020-R

Device Description : MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630755 Catalog Number : ZB-K021

Device Description : MIDFACE RECONSTRUCTION, SURGICAL GUIDE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuPlan® System - 00810007630762 Catalog Number : ZB-K030

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ PLATE DESIGN

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

AccuModel® - 00810007630779 Catalog Number : ZB-3D-M

Device Description : ANATOMICAL MODEL, MISCELLANEOUS

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

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