FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWEDE-VENT IMPLANT
K Number: K950577
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
25
Review Days
165
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SWEDE-VENT IMPLANT
- K Number
- K950577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core-Vent Corp.
- Date Received
- January 27, 1995
- Decision Date
- July 11, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
FDA 510(k)
FDA Class 2
·Dental
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 |
| 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 |
| K902968 | BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS | May 15, 1991 | Substantially Equivalent |