FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
K Number: K801274
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
6
Review Days
11
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Basic Information
- Device Name
- S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
- K Number
- K801274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pennwalt Corp.
- Date Received
- May 29, 1980
- Decision Date
- June 9, 1980
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by Pennwalt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833241 | INTREX | Oct 28, 1983 | Substantially Equivalent |
| K801860 | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX | Oct 10, 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 |