D/Sense

GUDID 00817051021331

D/Sense Crystal 1ml desensitizer gel syringe, 6

CENTRIX, INC.

Dental cavity varnish

• Primary Device ID: 00817051021331
• NIH Device Record Key: 0cb1269a-028c-4ee1-af41-c0aaa091ee88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D/Sense
• Version Model Number: 310106
• Company DUNS: 053707303
• Company Name: CENTRIX, INC.
• 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: true
• 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	00817051021331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120176

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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