Model: 5031885U0
Catalog: 5031885U0
DI: 08404535023398
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
UNIV OF MICH AS628BLCK PERIO 1P
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:
46cfc43b-4d31-4d6c-b0f9-388e6e2f70fe
Distribution Status:
In Commercial Distribution
DUNS Number:
082080136
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08404535023398
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16668
Name: Carbide dental bur, reusable
Definition:
A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.
FDA Product Codes
EJL
BUR, DENTAL