Device
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentium Co., Ltd.
Model: WFFD3606 Catalog: WFFD3606 DI: 08809544909761 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
Accessories, Implant, Dental, Endosseous
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: c6b41b68-520f-40e5-a487-a24687a81925
Distribution Status: In Commercial Distribution
DUNS Number: 689514395
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: 08809544909761
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
Device Sizes
Device Size - Size - @attributes - Unit: Millimeter
Device Size - Size - @attributes - Value: 32.3
Device Size - Size Type: Length