FDA.reportPublic FDA data

SUNBIO,INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135343613013534361SUNBIO,INC.1N2026-01-01129 Eunbong-ro Namdong-gu Incheon-si KR 21639

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2993681383447718K190144MucoPEGLFD2019-11-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LFD12019-11-05

PMN#

GUDID#

MucoPEG™ - MucoPEG™ is an artificial saliva intended to relieve the symptoms and discomfort of xerostomia (dry mouth) and was developed by SunBio, Inc. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The full chemical name of this ingredient is PEG tetra succinimidyl glutarate (PEG-SG). The additives in MucoPEG™ include mint for flavor and sodium bicarbonate for pH maintenance when dissolved in water. MucoPEG™ is formulated as a powder and packaged in a single-use packet. In general, PEG is well known for its excellent moisturizing effect in aqueous solutions due to its superior water-retaining capability. Therefore, the PEG derivative in MucoPEG™ also naturally exhibits the hydrophilic characteristics of PEG. Once in contact with the mucosa, the hydrophilic water-retaining property of PEG helps moisturize and lubricate the oral mucosa, thereby helping to relieve oral dryness. The oral mucosa of xerostomia patients consists of damaged epithelial cell layers caused by dryness. When MucoPEG™ is applied to the mucosa of xerostomia patients, it effectively fills and coats the damaged epithelial areas to relieve dry mouth symptoms and discomfort.

SunBio, Inc.

2026-06-01