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) (8) System, Image Processing, Radiological (LLZ) (8) Plate, Bone (JEY) (2)

Premarket Exempt

Clear

AccuPlan System - 00810007630328 Catalog Number : MC-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 - 00810007630335 Catalog Number : MC-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 - 00810007630342 Catalog Number : MC-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 - 00810007630359 Catalog Number : MC-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 - 00810007630366 Catalog Number : MC-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 - 00810007630373 Catalog Number : MC-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

AccuPlate - 00810007630410 Catalog Number : MC-K035

Device Description : MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

AccuPlan System - 00810007630427 Catalog Number : MC-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 - 00810007630441 Catalog Number : MC-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

AccuPlate - 00810007630458 Catalog Number : MC-PLT001

Device Description : MANDIBLE, 2.0 STRAIGHT

Device Class : 2

Duns Number: 144723868

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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