3D SYSTEMS, INC.

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Premarket Exempt
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Device Description : A physical template / guide that conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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 conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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 conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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 conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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 conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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 conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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

Prescription Use : Yes

Device Count : 1

Device Description : A physical template / guide that conforms to patients’ anatomy (Bony and / or Oc A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.

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

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