Device
The AIM Reference Marker is a temporary accessory used during digital implant workflows to provide spatial reference for scanning and photogrammetry procedures. The device is not i...
Manufacturer
LOUISIANA DENTAL IMPLANT LAB LLC
LOUISIANA DENTAL IMPLANT LAB LLC
Model: BNREFMUA1413
DI: 00860015404138
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-11
Current Version: 2026-05-19
Description
The AIM Reference Marker is a temporary accessory used during digital implant workflows to provide spatial reference for scanning and photogrammetry procedures. The device is not intended for fixation, stabilization, or load-bearing applications.
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:
cfcf8657-49b7-4b9a-ab01-dd99ef6f3215
Distribution Status:
In Commercial Distribution
DUNS Number:
077666070
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00860015404138
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61641
Name: Dental implant abutment analog, intraoral-scanning, single-use
Definition:
An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.
FDA Product Codes
DZE
Implant, Endosseous, Root-Form
Premarket Submissions
Submission Number:
K961384
Supplement Number:
000