FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BI-DENT
K Number: K982229
·
Decision Aug 13, 1998
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
18
Applicant Total
27
Review Days
90
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Basic Information
- Device Name
- BI-DENT
- K Number
- K982229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Valley Forge Scientific Corp.
- Date Received
- May 15, 1998
- Decision Date
- August 13, 1998
- Product Code
- EKZ
- 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 |
|---|---|---|---|
| EKZ | Unit, Electrosurgical, And Accessories, Dental | FDA class 2 | Dental |
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| K971986 | VALLEY FORGE BIPOLAR LOOP | Aug 26, 1997 | Substantially Equivalent |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | Jan 9, 1997 | Substantially Equivalent |
| K955764 | VALLEY FORGE BIPLOAR LOOP | Mar 1, 1996 | Substantially Equivalent |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | Dec 8, 1995 | Substantially Equivalent |
| K951985 | PRECISION BIPOLAR COAGULATOR | May 23, 1995 | Substantially Equivalent |