FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K Number: K950204
·
Decision Sep 27, 1995
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
51
Review Days
252
Basic Information
- Device Name
- 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
- K Number
- K950204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IMPLANT INNOVATIONS, INC.
- Date Received
- January 18, 1995
- Decision Date
- September 27, 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 |
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Other Clearances by IMPLANT INNOVATIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS | Jun 1, 2007 | Substantially Equivalent |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | Apr 30, 2007 | Substantially Equivalent |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | Apr 24, 2007 | Substantially Equivalent |
| K063403 | CONICAL ANGLED ABUTMENT | Mar 20, 2007 | Substantially Equivalent |
| K061629 | CERTAIN PREVAIL DENTAL IMPLANT | Feb 23, 2007 | Substantially Equivalent |
| K062432 | NANOTITE DENTAL IMPLANTS | Feb 22, 2007 | Substantially Equivalent |
| K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | Jul 21, 2006 | Substantially Equivalent |
| K061177 | PROVIDE TEMPORARY CYLINDER | May 16, 2006 | Substantially Equivalent |
| K060291 | PREFORMANCE TEMPORARY CYLINDER | Feb 27, 2006 | Substantially Equivalent |
| K053170 | PREFORMANCE POSTS | Feb 1, 2006 | Substantially Equivalent |