FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHECK-UP PLAQUE FIGHTING GUM
K Number: K860843
·
Decision May 21, 1986
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
4
Review Days
76
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Basic Information
- Device Name
- CHECK-UP PLAQUE FIGHTING GUM
- K Number
- K860843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Minnetonka, Inc.
- Date Received
- March 6, 1986
- Decision Date
- May 21, 1986
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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Other Clearances by Minnetonka, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883619 | MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K883566 | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K831488 | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | Jun 8, 1983 | Substantially Equivalent |