Model: 138334
Catalog: 138334
DI: D818138334
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Base metal alloy
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d0fb41ae-6848-4e5f-8b1e-c6bf100734d1
Distribution Status:
In Commercial Distribution
DUNS Number:
103095543
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:
D818138334
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 35857
Name: Dental casting non-noble alloy
Definition:
A material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.
FDA Product Codes
EJH
Alloy, Metal, Base