FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K Number: K900181
·
Decision Feb 20, 1991
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
25
Review Days
400
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Basic Information
- Device Name
- MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
- K Number
- K900181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Core-Vent Corp.
- Date Received
- January 16, 1990
- Decision Date
- February 20, 1991
- 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 Core-Vent Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K002614 | ADVENT IMPLANT SYSTEM | Dec 8, 2000 | Substantially Equivalent |
| K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, | Oct 30, 2000 | Substantially Equivalent |
| K950579 | MICRO-VENT IMPLANT | Jul 11, 1995 | Substantially Equivalent |
| K950576 | BIO-VENT X IMPLANT | Jul 11, 1995 | Substantially Equivalent |
| K950578 | SCREW-VENT IMPLANT | Jul 11, 1995 | Substantially Equivalent |
| K950575 | BIO-VENT IMPLANT | Jul 11, 1995 | Substantially Equivalent |
| K950577 | SWEDE-VENT IMPLANT | Jul 11, 1995 | Substantially Equivalent |
| K912059 | PRE-ANGLED ABUTMENTS | Feb 11, 1992 | Substantially Equivalent |
| K913782 | TCAL ABUTMENT | Oct 30, 1991 | Substantially Equivalent |
| K910585 | TSIR ANGLED ABUTMENTS | Oct 4, 1991 | Substantially Equivalent |