Device
Pilot drill for preparation of the osseous site prior to placement of ARCHTRACER fiducial markers.
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: 28mm
Catalog: AT-PLDR28MM
DI: 00810222550081
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
Pilot drill for preparation of the osseous site prior to placement 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:
fee40e4a-cc78-4ca2-b12e-33a06b7636e8
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:
00810222550081
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43311
Name: Pin/post dental drill bit
Definition:
A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.
FDA Product Codes
DZA
Drill, Dental, Intraoral