Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25
FDA 510(k) K981693 · Gebauer Co.
510(k) numberK981693
Submission
- Device name
- Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25
- Applicant
- Gebauer Co.
Cleveland, OH, US - Received
- May 13, 1998
- Decision date
- August 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFD – Saliva, Artificial
- Device class
- Unclassified
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| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)LFD · Traditional | Laclede, Inc. | 04/19/2024SE |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional | Eusa Pharma (Uk) Limited | 03/11/2024SE |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayLFD · Traditional | Gurunanda, LLC | 08/22/2023SE |
| K202689 | Dentilube SprayLFD · Traditional | Oxy2plus, LLC | 09/03/2021SE |
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 09/02/2020SE |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional | Oralabs, Inc. | 11/21/2019SE |
| K190144 | MucoPEGLFD · Traditional | Sunbio, Inc. | 11/05/2019SE |
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| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | 08/27/2026SE |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional | 05/07/2019SE |
| K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | 10/27/2017SE |
| K032671 | Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…MLY · Traditional | 03/17/2004SE |
| K031036 | Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…MLY · Traditional | 07/10/2003SE |
| K021726 | Gebauer's Instant IceMLY · Traditional | 12/12/2002SE |
| K002596 | Gebauer's Fluro Ethyl, Model 0386-0002-09MLY · Traditional | 02/15/2001SE |
| K001624 | Gebauer's Fluori-Methane, Model 0386-0003-04MLY · Traditional | 01/25/2001SE |
| K991514 | Gebauer's Chloride Fine NozzeMLY · Traditional | 07/16/1999SE |
| K930915 | Fluori Methane Ss- a Vapocoolant/Skin Ref. DeviceMLY · Traditional | 09/29/1994SE |
Questions and answers
When was Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 cleared by the FDA?
Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 (K981693) received a 510(k) decision of Substantially Equivalent on August 6, 2001, 1,181 days after the submission was received.
What is the product code of K981693?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.