GC Oral Moisturizing Gel
FDA 510(k) K101346 · GC America, Inc.
510(k) numberK101346
Submission
- Device name
- GC Oral Moisturizing Gel
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- May 13, 2010
- Decision date
- January 27, 2011
- 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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| 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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Questions and answers
When was GC Oral Moisturizing Gel cleared by the FDA?
GC Oral Moisturizing Gel (K101346) received a 510(k) decision of Substantially Equivalent on January 27, 2011, 259 days after the submission was received.
What is the product code of K101346?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.