Device
Young Hygiene Handpiece - Purple, 3 Purple Nosecones
Manufacturer
YOUNG DENTAL MANUFACTURING I, LLC
YOUNG DENTAL MANUFACTURING I, LLC
Model: 296267
Catalog: 296267
DI: 00302730001723
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Young Hygiene Handpiece - Purple, 3 Purple Nosecones
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:
dbcf2ed6-1d24-4062-9a19-33f565381785
Distribution Status:
In Commercial Distribution
DUNS Number:
006309355
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Inner
Item #1 - Device ID:
10302730001720
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00302730001723
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00302730001723
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
20302730001727
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
12
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10302730001720
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 44909
Name: Pneumatic dental scaling/debridement system handpiece
Definition:
A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.
FDA Product Codes
EFB
Handpiece, air-powered, dental
Premarket Submissions
Submission Number:
K974671
Supplement Number:
000