Dental Basics

GUDID 00850061028020

Phosphor Plate Barrier Envelopes, Size 0, Side Opening

Dental Basics Inc.

Digital imaging cassette

• Primary Device ID: 00850061028020
• NIH Device Record Key: ddfbb7f8-aae6-46ba-8891-d3620fd138ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Basics
• Version Model Number: BE10
• Company DUNS: 119194176
• Company Name: Dental Basics Inc.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061028020 [Unit of Use]
GS1	20850061028024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163447

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-16
• Device Publish Date: 2024-05-08

On-Brand Devices [Dental Basics]

• 20850061028208: Disposable Prophy Angles 60° Turn Reciprocating Soft Green
• 20850061028192: Disposable Prophy Angles 60° Turn Reciprocating Regular Blue
• 20850061028185: Disposable Prophy Angles 105° Angle Head Soft Green
• 20850061028178: Disposable Prophy Angles 105° Angle Head Regular Blue
• 20850061028161: Disposable Prophy Angles 90° Angle Head Soft Green
• 00850061028150: Disposable Prophy Angles 90° Angle Head Regular Blue
• 00850061028143: Prophy Angle Air Motor, Air Motor + 3 Nose Cones
• 20850061028130: Air-Water Syringe Tips, Assorted Colours
• 20850061028123: Recycled Platsic Micro Applicators, Extra Fine, Dark Green
• 20850061028116: Recycled Platsic Micro Applicators, Fine, Medium Green
• 20850061028109: Recycled Platsic Micro Applicators, Regular, Light Green
• 20850061028093: Micro Applicators, Cylinder, White
• 20850061028086: Micro Applicators, Extra Fine, Light Lavender
• 20850061028079: Micro Applicators, Fine, Light Green
• 20850061028062: Micro Applicators, Regular, Light Blue
• 20850061028055: Phosphor Plate Barrier Envelopes, Size 0, Top Opening
• 20850061028048: Phosphor Plate Barrier Envelopes, Size 2, Side Opening
• 20850061028031: Phosphor Plate Barrier Envelopes, Size 1, Side Opening
• 20850061028017: Phosphor Plate Barrier Envelopes, Size 2, Top Opening
• 20850061028000: Phosphor Plate Barrier Envelopes, Size 1, Top Opening
• 00850061028020: Phosphor Plate Barrier Envelopes, Size 0, Side Opening