FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K Number: K962576
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
21
Review Days
224
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Basic Information
- Device Name
- SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K Number
- K962576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Calcitek, Inc.
- Date Received
- July 1, 1996
- Decision Date
- February 10, 1997
- 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 Calcitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962106 | SPLINE DENTAL IMPLANT SYSTEMS | Aug 29, 1996 | Substantially Equivalent |
| K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Mar 8, 1996 | Substantially Equivalent |
| K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Feb 8, 1996 | Substantially Equivalent |
| K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | Feb 8, 1996 | Substantially Equivalent |
| K946345 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM | Nov 15, 1995 | Substantially Equivalent |
| K946319 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Nov 15, 1995 | Substantially Equivalent |
| K946311 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Oct 4, 1995 | Substantially Equivalent |
| K943180 | INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM | Sep 21, 1995 | Substantially Equivalent |
| K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | May 16, 1995 | Substantially Equivalent |
| K941608 | INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING | May 5, 1995 | Substantially Equivalent |