Home › Device types › LFD
Saliva, Artificial
FDA product code LFD · Class U · Unknown
63
Registered devices
411
Adverse events
6
Recalls
50
510(k) clearances
Devices with this code
Biotene — Haleon US Holdings LLCAllday Spray 4 pk — ELEVATE ORAL CARE, LLCBiotene — Haleon US Holdings LLCAllday Spray 2 pk — ELEVATE ORAL CARE, LLCbioXtra — Lifestream PharmaTHERABREATH RINSE — CHURCH & DWIGHT CO., INC.THERABREATH RINSE — CHURCH & DWIGHT CO., INC.Moisyn Dry Mouth Oral Mist — SYNEDGEN, INC.Moi-stir 4 oz — Century Pharmaceuticals IncLubricity Innovative Oral Spray — You First Services, Inc.Biotene — Haleon US Holdings LLCSmartMouth — Triumph Pharmaceuticals Inc.Biotene — Haleon US Holdings LLCBiotene — Haleon US Holdings LLCTHERABREATH LOZENGE — CHURCH & DWIGHT CO., INC.SalivaMAX — Forward Science Technologies LLCCVS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDAllday GEL — ELEVATE ORAL CARE, LLCBiotene — Haleon US Holdings LLCAllday Spray — ELEVATE ORAL CARE, LLCPovi-One — ELEVATE ORAL CARE, LLCPeriovance Dry Mouth Gel — ORABIO, INC.SalivaMAX — Forward Science Technologies LLCMoisyn Dry Mouth Oral Rinse — SYNEDGEN, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-11 | RECORDATI RARE DISEASES INC. | Out of specification stability test result for the Caphosol B solution from process validation lots |
| 2021-02-18 | Sunstar Americas, Inc. | The product may be contaminated with Burkholderia cepacia |
| 2013-10-17 | GlaxoSmithKline, LLC. | Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. |
| 2007-01-19 | Gebauer Company | Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing. |
| 2005-04-22 | Kingswood Laboratories,Inc | Contaminated with Aspergillus and Penicillum molds. |
| 2004-02-23 | Gebauer Co | The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty. |
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