Cleared Traditional

K190144 - MucoPEG (FDA 510(k) Clearance)

K190144 · Sunbio, Inc. · Dental device
Nov 2019
Decision
280d
Days
-
Risk

K190144 is an FDA 510(k) clearance for the MucoPEG. This device is classified as a Saliva, Artificial.

Submitted by Sunbio, Inc. (Gunpo-Si, KR). The FDA issued a Cleared decision on November 5, 2019, 280 days after receiving the submission on January 29, 2019.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K190144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2019
Decision Date November 05, 2019
Days to Decision 280 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -