Device
HD-3.75, 5mm
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: HD-3.75, 5mm
DI: 05999112402732
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
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ba436eba-1bb9-496e-9796-301ae5ec5c93
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:
05999112402732
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44880
Name: Dental implant suprastructure, temporary, preformed, single-use
Definition:
A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
FDA Product Codes
NHA
Abutment, Implant, Dental, Endosseous
Premarket Submissions
Submission Number:
K182219
Supplement Number:
000