Device
Monotype root-form dental implant made of Zirconia Familiy Z5m(t)-neo
Manufacturer
Z-Systems AG
Z-Systems AG
Model: Z5m(t)-neo-5012
Catalog: Z5m(t)-neo-5012
DI: 07640166763727
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-17
Current Version: 2026-05-25
Description
Monotype root-form dental implant made of Zirconia Familiy Z5m(t)-neo
Size Z5m(t)-neo-5012
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f6267807-5202-4540-a6d8-c98a29822a82
Distribution Status:
In Commercial Distribution
DUNS Number:
483189556
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07640166763727
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55848
Name: Screw endosteal dental implant, one-piece
Definition:
A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.
FDA Product Codes
DZE
Implant, Endosseous, Root-Form
Premarket Submissions
Submission Number:
K150021
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
12
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
5
Item #2 - Size Type:
Outer Diameter