Model: OBEV0415
Catalog: OBEV0415
DI: 00850087286152
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Digital Mounting Adapter Denar Mk320
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b57c25c2-ac8f-4a72-b866-7b1392451683
Distribution Status:
In Commercial Distribution
DUNS Number:
081523806
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
00850087286152
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35700
Name: Facebow
Definition:
A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.
FDA Product Codes
EHY
Tray, Impression, Preformed