FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX
K Number: K801860
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX
- K Number
- K801860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pennwalt Corp.
- Date Received
- August 5, 1980
- Decision Date
- October 10, 1980
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
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Other Clearances by Pennwalt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833241 | INTREX | Oct 28, 1983 | Substantially Equivalent |
| K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | Jun 9, 1980 | Substantially Equivalent |
| K800133 | PANOREX II DENTAL X-RAY UNIT | Mar 3, 1980 | Substantially Equivalent |
| K800063 | XR-710 | Mar 3, 1980 | Substantially Equivalent |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Aug 2, 1978 | Substantially Equivalent |