3D SYSTEMS, INC.

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Premarket Exempt
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Device Description : A physical template / guide that is positioned on patients’ anatomy (Bony and / A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

Device Description : A physical template / guide that is positioned on patients’ anatomy (Bony and / A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ

Prescription Use : Yes

Device Count : 1

Device Description : A physical template / guide that is positioned on patients’ anatomy (Bony and / A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : DZJ, LLZ, PPT

Prescription Use : Yes

Device Count : 1

Device Description : A physical template / guide that is positioned on patients’ anatomy (Bony and / A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Device Description : A physical template that can be positioned at the osteotomy site that allows the A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Device Description : A physical template that can be positioned at the osteotomy site that allows the A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : DZJ, LLZ, PPT

Prescription Use : Yes

Device Count : 1

Device Description : A template that is used as an aide to pre-contour patient’s implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ

Prescription Use : Yes

Device Count : 1

Device Description : A template that is used as an aide to pre-contour patient’s implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : DZJ, LLZ

Prescription Use : Yes

Device Count : 1