Dental Basics

Basic Information

• Brand Name: Dental Basics
• Primary DI: 20850061028024
• Version / Model: BE10
• Company Name: Dental Basics Inc.
• Labeler DUNS: 119194176
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-05-08
• Public Version: 2
• Public Version Date: 2024-06-19
• Public Version Status: Update
• Public Device Record Key: ddfbb7f8-aae6-46ba-8891-d3620fd138ee

Device Description

Phosphor Plate Barrier Envelopes, Size 0, Side Opening

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44823	Digital imaging cassette	A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850061028020	GS1
Primary	20850061028024	GS1

Premarket Submissions

Submission Number	Supplement Number
K163447	000