Device
Handheld driver for placement and removal of ARCHTRACER fiducial markers.
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: 23mm
DI: 00810222550043
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Handheld driver for placement and removal of ARCHTRACER fiducial markers.
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:
8acbcd4c-ecfb-44b8-abfb-f7023010a15e
Distribution Status:
In Commercial Distribution
DUNS Number:
145248707
Device Count:
1
DM Exempt:
No
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810222550043
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64627
Name: Dental implant holding endpiece, reusable
Definition:
A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device.
FDA Product Codes
NDP
Accessories, Implant, Dental, Endosseous