510(k) K181134
- Device
- 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
- 510(k) number
- K181134
- Product code
- LFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-13
- Date received
- 2018-04-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Saliva, Artificial
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Dental
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Liz Bastian
- Address
- 301 E. Central Rd. Schaumburg IL US 60195 60195
FDA Registration Numbers#
- 3012328521
- 3013534361
- 2936950
- 3007617180
- 1025121
- 1648579
- 3027909953
- 3014468707
- 3032909920
- 1413475
- 2000004234
- 9613953
- 9613740
- 3014539253
- 3010143501
- 3014469173
- 3012293198
- 3010400793
- 3030444281
- 3012943922
- 9612300
- 3030049002
- 3008826993
- 3003896222
- 3001237145
- 2022474
- 2133714
- 3007935577
- 3038718579
- 3010809218
- 1313525
- 1410097
- 3014268952
- 2280705
- 3011647051
- 1831301
- 9615332
- 3009603151
- 1530449
- 1819174
Source Documents#
Other 510(k) Records For Product Code LFD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. | 2025-05-19 |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024-04-19 |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | 2024-03-11 |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | Gurunanda, LLC | 2023-08-22 |
| K202689 | Dentilube Spray | Oxy2plus, LLC | 2021-09-03 |
| K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021-04-05 |
| K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020-09-02 |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Oralabs, Inc. | 2019-11-21 |
| K190144 | MucoPEG | Sunbio, Inc. | 2019-11-05 |
| K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018-10-11 |
| K173808 | Voutia™ | Jeffrey Ward Cash, Dds | 2018-07-27 |
| K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist | Syendgen, Inc. | 2018-03-19 |
| K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 |
Legacy Summary#
summary
FDA Review#
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