FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUORIDE GEL DISPOSABLE TRAY
K Number: K770064
·
Decision Jan 14, 1977
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
7
Applicant Total
6
Review Days
3
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Basic Information
- Device Name
- FLUORIDE GEL DISPOSABLE TRAY
- K Number
- K770064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6870
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lorvic Corp.
- Date Received
- January 11, 1977
- Decision Date
- January 14, 1977
- Product Code
- KMT
- 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 |
|---|---|---|---|
| KMT | Tray, Fluoride, Disposable | FDA class 1 | Dental |
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Other Clearances by Lorvic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871615 | U. V. GERMICIDAL UNIT | Sep 11, 1987 | Substantially Equivalent |
| K780263 | SHIELD | May 3, 1978 | Substantially Equivalent |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Jan 14, 1977 | Substantially Equivalent |
| K760620 | SALIVA EJECTOR | Sep 21, 1976 | Substantially Equivalent |
| K760121 | IMPULSE HEAT SEALER | Jul 16, 1976 | Substantially Equivalent |