Model: CMC/CMW
DI: 06974208588179
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e273ca77-e322-44d8-98a6-f590318ce122
Distribution Status:
In Commercial Distribution
DUNS Number:
554479198
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:
06974208588179
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44727
Name: Dental porcelain/ceramic restoration kit
Definition:
A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.
FDA Product Codes
EIH
Powder, Porcelain
Premarket Submissions
Submission Number:
K192262
Supplement Number:
000