Device
S1a
Manufacturer
S.G.S. International Orvosi Eszközöket Gyártó és Forgalmazó Kereskedelmi Korlátolt Felelősségű Társaság
Model: S1a DI: 05999112407539 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
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: 60691959-450d-4f5b-abe9-2f6c04b46de9
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: 05999112407539
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61647
Name: Dental prosthesis/implant abutment screw
Definition:
A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.
FDA Product Codes
NHA
Abutment, Implant, Dental, Endosseous