FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OCCLUDE
K Number: K912632
·
Decision Jan 17, 1992
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
9
Applicant Total
8
Review Days
217
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Basic Information
- Device Name
- OCCLUDE
- K Number
- K912632
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6140
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pascal Co., Inc.
- Date Received
- June 14, 1991
- Decision Date
- January 17, 1992
- Product Code
- EFH
- 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 |
|---|---|---|---|
| EFH | Paper, Articulation | FDA class 1 | Dental |
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|---|---|---|---|
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| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Jul 7, 2004 | Substantially Equivalent |
| K040661 | RADENT PROPHY PASTE | Jun 9, 2004 | Substantially Equivalent |
| K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT | May 27, 2003 | Substantially Equivalent |
| K030488 | FLUORILAQ | May 2, 2003 | Substantially Equivalent |
| K911259 | HYDENT | Jun 6, 1991 | Substantially Equivalent |