FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDENT
K Number: K911259
·
Decision Jun 6, 1991
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
9
Applicant Total
8
Review Days
76
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Basic Information
- Device Name
- HYDENT
- K Number
- K911259
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6140
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pascal Co., Inc.
- Date Received
- March 22, 1991
- Decision Date
- June 6, 1991
- 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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| K030488 | FLUORILAQ | May 2, 2003 | Substantially Equivalent |
| K912632 | OCCLUDE | Jan 17, 1992 | Substantially Equivalent |