Device
P5D-6.0-10mm
Manufacturer
S.G.S. International Orvosi Eszközöket Gyártó és Forgalmazó Kereskedelmi Korlátolt Felelősségű Társaság
S.G.S. International Orvosi Eszközöket Gyártó és Forgalmazó Kereskedelmi Korlátolt Felelősségű Társaság
Model: P5D-6.0-10mm
DI: 05999112402107
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fb48093e-22b2-4ac8-8c2b-f2e3ddbd8fa8
Distribution Status:
In Commercial Distribution
DUNS Number:
860799006
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05999112402107
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55849
Name: Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.
FDA Product Codes
DZE
Implant, Endosseous, Root-Form
Premarket Submissions
Submission Number:
K182219
Supplement Number:
000