FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE
K Number: K962941
·
Decision Oct 8, 1996
Classifications
1
FEI Numbers
150
Registration Numbers
151
Same Product Code
30
Applicant Total
1
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE
- K Number
- K962941
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deep Trading Corp.
- Date Received
- July 29, 1996
- Decision Date
- October 8, 1996
- Product Code
- LCN
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| LCN | Scraper, Tongue | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCN), ordered by most recent decision date.
MIRACLEBREATH TONGUE CLEANER
FDA 510(k)
FDA Class 1
·Dental
ORALGIENE TONGUE CLEANER
FDA 510(k)
FDA Class 1
·Dental
UNIK TONGUE CLEANER
FDA 510(k)
FDA Class 1
·Dental
BREATHTIQUE TONGUE SCRAPER
FDA 510(k)
FDA Class 1
·Dental
BREATHAID TONGUE SCRAPER
FDA 510(k)
FDA Class 1
·Dental
COPPER TONGUE SCRAPER
FDA 510(k)
FDA Class 1
·Dental