DASH

GUDID 00075020034311

Discus Dental, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00075020034311
• NIH Device Record Key: adfca687-df21-416b-97b0-a4807f1f7d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DASH
• Version Model Number: DIS429/01
• Company DUNS: 831726109
• Company Name: Discus Dental, LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075020034311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062176

FDA Product Code

• LBH: VARNISH, CAVITY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-22
• Device Publish Date: 2016-09-07

Devices Manufactured by Discus Dental, LLC

• 08710103611967 - Philips Zoom: 2024-01-30
• 00075020035011 - Philips Zoom: 2020-10-01
• 08710103632122 - Philips Zoom: 2020-10-01
• 00075020034236 - Philips Sonicare BreathRx: 2020-09-07
• 00075020034243 - Philips Sonicare BreathRx: 2020-09-07
• 00075020044129 - Philips Zoom: 2020-09-07
• 00075020048004 - Philips Sonicare BreathRx: 2020-09-07
• 00075020048035 - Philips Sonicare BreathRx: 2020-09-07