Model: S500-6NA
Catalog: S500-6NA
DI: 07640397422028
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
One step, pre-sterilization handpiece maintenance spray
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d187991f-ce58-4233-84bb-3ede344e0e74
Distribution Status:
In Commercial Distribution
DUNS Number:
480152811
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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 - Pkg Type:
Carton
Item #1 - Device ID:
17640397422025
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
6
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07640397422028
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07640397422028
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
07540196002356
Item #3 - Device ID Type:
Previous
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 15772
Name: Surgical instrument maintenance lubricant
Definition:
A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.
FDA Product Codes
EFB
Handpiece, Air-Powered, Dental
Premarket Submissions
Submission Number:
K062418
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
122
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Protect from sunlight.