SCHICK ELITE

Basic Information

• Brand Name: SCHICK ELITE
• Primary DI: D764B10741521
• Version / Model: B1074152
• Company Name: SIRONA DENTAL, INC.
• Labeler DUNS: 078613913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: e8603bca-3fba-45b1-a6ae-e78995a2fb62

Device Description

SCHICK AIMRIGHT - VERTICAL BITEWING AUTOCLAVABLE HOLDER S1 (2) BLUE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MUH	System,X-Ray,Extraoral Source,Digital	Dental	872.1800	2
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2
EHD	Unit, X-Ray, Extraoral With Timer	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D764B10741521	HIBCC
Unit of Use	D764B10741020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072134	000