FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ORAL BALANCE LIQUID/ GEL
K Number: K061331
·
Decision Jul 25, 2006
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
5
Review Days
74
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Basic Information
- Device Name
- ORAL BALANCE LIQUID/ GEL
- K Number
- K061331
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laclede, Inc.
- Date Received
- May 12, 2006
- Decision Date
- July 25, 2006
- 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 |
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Other Clearances by Laclede, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Apr 19, 2024 | Substantially Equivalent |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Oct 11, 2018 | Substantially Equivalent |
| K162235 | LUVENA VAGINAL MOISTURIZER & LUBRICANT | Mar 24, 2017 | Substantially Equivalent |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | Dec 29, 2015 | Substantially Equivalent |