FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Oral-B Dry Mouth Oral Rinse
K Number: K201277
·
Decision Sep 2, 2020
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
5
Review Days
112
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Basic Information
- Device Name
- Oral-B Dry Mouth Oral Rinse
- K Number
- K201277
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Procter & Gamble Company
- Date Received
- May 13, 2020
- Decision Date
- September 2, 2020
- Product Code
- LFD
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFD), ordered by most recent decision date.
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Caphosol® Artifical Saliva (32 doses sachet box)
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GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
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Dentilube Spray
FDA 510(k)
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Other Clearances by The Procter & Gamble Company
| K Number | Device Name | ||
|---|---|---|---|
| K203567 | Oral-B Dry Mouth Oral Rinse | Apr 5, 2021 | Substantially Equivalent |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | Aug 27, 2020 | Substantially Equivalent |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | Jan 9, 2014 | Substantially Equivalent |
| K113699 | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | Jan 12, 2012 | Substantially Equivalent |