UDI device identifier

SenzAway 1

UDI device identifier 00010705400456 · MAJESTIC DRUG CO. INC.

Key facts

Primary DI 00010705400456
Brand name SenzAway
Version or model 1
Company MAJESTIC DRUG CO. INC.
DUNS number 001496777
Product code LBH
GMDN term Dental cavity varnish
Premarket submission K120176
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jul 27, 2016
Version date Jul 6, 2018
Description SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and hot food and liquids. One application should relieve sensitivity of teeth immediately and will last at least three months (individual results may vary)

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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