Denticator

Basic Information

• Brand Name: Denticator
• Primary DI: 00302737530035
• Version / Model: 753003
• Catalog Number: 753003
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Labeler DUNS: 006309355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-16
• Public Version: 1
• Public Version Date: 2022-10-24
• Public Version Status: New
• Public Device Record Key: 68e79701-333e-4a08-85e8-4c5753ea6981

Device Description

Denticator ProphyPal, Slow Speed Hygiene Handpiece, Assorted Colors Variety Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFB	Handpiece, air-powered, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44909	Pneumatic dental scaling/debridement system handpiece	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10302737530032	GS1	Box	3	In Commercial Distribution
Primary	00302737530035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K974671	000