Device
6.0mm Ti-Link Compatible with Megagen Anyridge Implant System
Manufacturer
Creo Dent Hudson Valley, Inc.
Creo Dent Hudson Valley, Inc.
Model: MGAR6
DI: D124MGAR60
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
6.0mm Ti-Link Compatible with Megagen Anyridge Implant System
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:
8f22d257-c8c0-46c5-a005-739cb7320ead
Distribution Status:
In Commercial Distribution
DUNS Number:
071221112
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D124MGAR60
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 63349
Name: Dental implant suprastructure, permanent, custom-made
Definition:
A custom-made device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; an abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure and is manufactured for a specific patient.
FDA Product Codes
NHA
Abutment, Implant, Dental, Endosseous
Premarket Submissions
Submission Number:
K251515
Supplement Number:
000