FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRON ROOT CANAL FILLING MATERIAL
K Number: K801482
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
34
Review Days
66
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Basic Information
- Device Name
- HYDRON ROOT CANAL FILLING MATERIAL
- K Number
- K801482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- National Patent Development Corp.
- Date Received
- May 16, 1980
- Decision Date
- July 21, 1980
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by National Patent Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843974 | VARIABLE TEMPERATURE CAUTERY DEVICE | Feb 26, 1985 | Substantially Equivalent |
| K832699 | HYDRON WOUND DRESSING FAST SEAT KIT | Apr 27, 1984 | Substantially Equivalent |
| K822793 | PIO ROOT CANAL INDICATOR | Oct 22, 1982 | Substantially Equivalent |
| K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS | Mar 11, 1982 | Substantially Equivalent |
| K820006 | ZEON COMPOSITE RESIN SYSTEM | Jan 22, 1982 | Substantially Equivalent |
| K811446 | HYDRON WOUND DRESSING KIT | Jun 12, 1981 | Substantially Equivalent |
| K801483 | MARK IV SYRINGE | Jul 21, 1980 | Substantially Equivalent |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | Jul 21, 1980 | Substantially Equivalent |
| K792136 | HYPO-ALLERGENIC PLASTIC TAPE | Jan 16, 1980 | Substantially Equivalent |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | Dec 20, 1979 | Substantially Equivalent |