Model: 5032032U0
Catalog: 5032032U0
DI: 08404535025927
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
DECA A631BLACK BLOCK 1P
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7e70da82-f383-4c02-943f-ec730c8a2740
Distribution Status:
In Commercial Distribution
DUNS Number:
082080136
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
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:
08404535025927
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45525
Name: Diamond dental bur, single-use
Definition:
A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.
FDA Product Codes
FRG
Wrap, sterilization