Device
Ø6/ L=9/ Non-Hex/ Pick-up
Manufacturer
Megagen Implant Co. Ltd
Model: AONIP6009N Catalog: AONIP6009NT DI: 08800292994474 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Ø6/ L=9/ Non-Hex/ Pick-up
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: b105b4fd-9088-4c4c-b2c8-6a168e3104b2
Distribution Status: In Commercial Distribution
DUNS Number: 687388178
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08800292994474
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45714
Name: Fixture/appliance dental drill bit, reusable
Definition:
A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.
FDA Product Codes
NDP
Accessories, Implant, Dental, Endosseous