Model: FD400-neo
Catalog: FD400-neo
DI: 07640166763741
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-17
Current Version: 2026-05-25
Description
Form Drill for Zm5(t)-neo Ø4.0 mm
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:
60be9d41-8a58-44fd-af7a-fd82f2337f6b
Distribution Status:
In Commercial Distribution
DUNS Number:
483189556
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07640166763741
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