Product code LFD ยท Class U
Saliva, Artificial
1510(k)s in 12 months (50 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in LFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Kingswood Laboratories, Inc. | 3 | 1 |
| Gebauer Co. | 1 | 2 |
| Glaxosmithkline Consumer Healthcare (Gskch) | 3 | 0 |
| Laclede, Inc. | 3 | 0 |
| The Procter & Gamble Co. | 3 | 0 |
| Elevate Oral Care | 2 | 0 |
| Eusa Pharma (Uk) Limited | 2 | 0 |
| Inpharma A.S. | 2 | 0 |
| Sunstar Americas, Inc. | 1 | 1 |
| Bartor Pharmacal Co., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2025 | RECORDATI RARE DISEASES INC. Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution
(32 sachets Solution A Phosphate, 32 sachets Solution B Calcium) Open, Classified |
LFD | K234015 |
| Feb 18, 2021 | Sunstar Americas, Inc. SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moistu Terminated |
LFD | K181134 |
| Nov 13, 2013 | GlaxoSmithKline, LLC. Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Towns Terminated |
LFD | K123731 |
| Mar 20, 2007 | Gebauer Company Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio Terminated |
LFD | K981693 |
| May 11, 2005 | Kingswood Laboratories,Inc Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-70 Terminated |
LFD | K851026 |
| Jul 20, 2004 | Gebauer Co Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH. Terminated |
LFD | K981693 |
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