FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTURE CLEANSER & TOOTHPASTE IN ONE
K Number: K780254
·
Decision Mar 9, 1978
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
13
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- DENTURE CLEANSER & TOOTHPASTE IN ONE
- K Number
- K780254
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3530
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Richardson Merrel, Inc.
- Date Received
- February 16, 1978
- Decision Date
- March 9, 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
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ORAL SAFE
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Other Clearances by Richardson Merrel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790339 | CONCEPT II | Jul 17, 1979 | Substantially Equivalent |