FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BICON BONE SCREW SYSTEM
K Number: K982488
·
Decision Jan 26, 1999
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
13
Review Days
193
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Basic Information
- Device Name
- BICON BONE SCREW SYSTEM
- K Number
- K982488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bicon, Inc.
- Date Received
- July 17, 1998
- Decision Date
- January 26, 1999
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Bicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT | Nov 21, 2006 | Substantially Equivalent |
| K051091 | SYNTHOGRAFT | Sep 1, 2005 | Substantially Equivalent |
| K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | Apr 22, 2005 | Substantially Equivalent |
| K050408 | BICON ORTHODONTIC IMPLANT SYSTEM | Apr 7, 2005 | Substantially Equivalent |
| K031568 | BICONITE SURFACE TREATMENT | Nov 23, 2004 | Substantially Equivalent |
| K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT | Nov 15, 2004 | Substantially Equivalent |
| K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM | Jan 29, 2003 | Substantially Equivalent |
| K010185 | 6.0 X 5.7MM DENTAL IMPLANT | Dec 30, 2002 | Substantially Equivalent |
| K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT | Jan 11, 2000 | Substantially Equivalent |
| K973056 | BONE GRAFT SCREW SYSTEM | Nov 12, 1997 | Substantially Equivalent |