G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
FDA 510(k) clearance K181134 · decided 2018-07-13
Clearance details
- K-number
- K181134
- Device name
- G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
- Applicant
- Sunstar Americas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-30
- Decision date
- 2018-07-13
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- LFD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Allday Moisturizing Rinse (K253778) | Elevate Oral Care | 2026-02-27 |
| CloSYS® Dry Mouth Sensitive Mouth Rinse (K250390) | Rowpar Pharmaceuticals, Inc. | 2025-05-19 |
| Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (K240508) | Laclede, Inc. | 2024-04-19 |
| Caphosol® Artifical Saliva (32 doses sachet box) (K234015) | Eusa Pharma (Uk) Limited | 2024-03-11 |
| GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (K231205) | Gurunanda, LLC | 2023-08-22 |
| Dentilube Spray (K202689) | Oxy2plus, LLC | 2021-09-03 |
| Oral-B Dry Mouth Oral Rinse (K203567) | The Procter & Gamble Company | 2021-04-05 |
| Oral-B Dry Mouth Oral Rinse (K201277) | The Procter & Gamble Company | 2020-09-02 |
| CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839) | Oralabs, Inc. | 2019-11-21 |
| MucoPEG (K190144) | Sunbio, Inc. | 2019-11-05 |
| SmartMouth DryMouth Oral Rinse (K181194) | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (K180680) | Laclede, Inc. | 2018-10-11 |
Recalls involving this device
No recalls on record reference this clearance.