Identity
- Trade Name
- Moisyn Dry Mouth Oral Rinse FDA UDI
- Generic Name
- Artificial saliva FDA UDI
- Model / Reference
- 59.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852181005141 FDA UDI
- 510(k) Number
- K173237 FDA UDI
- FDA Product Code
- LFD FDA UDI
- GMDN Term
- Artificial saliva FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Artificial saliva
Moisyn Dry Mouth Oral Rinse by Synedgen, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial saliva.
- THERABREATH RINSE — Church & Dwight Co., Inc. · U
- Biotene — Haleon US Holdings LLC · U
- Biotene — Haleon US Holdings LLC · U
- Salivea — Laclede, Inc. · U
- SalivaMAX — FORWARD SCIENCE TECHNOLOGIES LLC · U
- Biotene Oral Rinse Dry Mouth — Haleon US Holdings LLC · U
- THERABREATH LOZENGE — Church & Dwight Co., Inc. · U
- Periovance Dry Mouth Gel — ORABIO, INC. · U
Cleared under the same submission
K173237 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Synedgen, Inc.
Sources (1)
- FDA UDI c95b6c95-7c38-41e3-9398-a0d35f9d2d35 34 fields · synced Jun 7, 2026