FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K Number: K181839
·
Decision Nov 21, 2019
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
2
Review Days
498
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Basic Information
- Device Name
- CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
- K Number
- K181839
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oralabs, Inc.
- Date Received
- July 11, 2018
- Decision Date
- November 21, 2019
- 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
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Dentilube Spray
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Other Clearances by Oralabs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113326 | ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD | Jun 27, 2012 | Substantially Equivalent |