Model: 605871
DI: D2486058711
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-21
Description
Dental prophy brushes
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
287b6969-b685-4cd1-bec3-8040f3675e37
Distribution Status:
In Commercial Distribution
DUNS Number:
009277971
Device Count:
50
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
D2486058710
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D2486058711
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 64015
Name: Dental-professional prophylaxis brush, single-use
Definition:
A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.
FDA Product Codes
EHK
Cup, Prophylaxis