Relief ACP

GUDID 00075020043900

Discus Dental, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00075020043900
• NIH Device Record Key: 031cc6df-bb30-4938-b3f0-2a23f3e31298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relief ACP
• Version Model Number: DIS445/01
• Company DUNS: 831726109
• Company Name: Discus Dental, LLC
• Device Count: 6
• 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	00075020043900 [Primary]
GS1	00075020065797 [Unit of Use]

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

On-Brand Devices [Relief ACP]

• 00075020065469: DIS455/01
• 00075020043900: DIS445/01
• 00075020043863: DIS272/30
• 00075020034403: DIS455/02
• 00075020089892: DIS571/99