FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SANI-DENT DENTURE CLEANER
K Number: K781779
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
13
Applicant Total
1
Review Days
156
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
- SANI-DENT DENTURE CLEANER
- K Number
- K781779
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3530
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sandi-Dent
- Date Received
- June 5, 1978
- Decision Date
- November 8, 1978
- Product Code
- JER
- 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 |
|---|---|---|---|
| JER | Cleaner, Denture, Mechanical | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JER), ordered by most recent decision date.
DENTA PLUS
FDA 510(k)
FDA Class 1
·Dental
ULTRASONIC DENTURE CLEANER
FDA 510(k)
FDA Class 1
·Dental
DENTURE CLEANSERS
FDA 510(k)
FDA Class 1
·Dental
DURACLEAN DENTURE CLEANER
FDA 510(k)
FDA Class 1
·Dental
ORAL SAFE
FDA 510(k)
FDA Class 1
·Dental
ORAL SAFE
FDA 510(k)
FDA Class 1
·Dental