FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ITI DISTANCE SYSTEM
K Number: K931993
·
Decision Apr 26, 1994
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
14
Review Days
368
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Basic Information
- Device Name
- ITI DISTANCE SYSTEM
- K Number
- K931993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Straumann Co.
- Date Received
- April 23, 1993
- Decision Date
- April 26, 1994
- 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 The Straumann Co.
| K Number | Device Name | ||
|---|---|---|---|
| K041070 | STRAUMANN TEMPORARY COPING | Jul 23, 2004 | Substantially Equivalent |
| K040646 | STRAUMANN GRANULES | May 3, 2004 | Substantially Equivalent |
| K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | Apr 30, 2004 | Substantially Equivalent |
| K993862 | MODUS SAGITTAL SPLIT PLATE | Dec 29, 1999 | Substantially Equivalent |
| K962023 | PLASTIC PROTECTION HEALING CAPS | Aug 15, 1996 | Substantially Equivalent |
| K960634 | TITANIUM HEALING CAPS | Jun 18, 1996 | Substantially Equivalent |
| K955281 | ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES | Mar 15, 1996 | Substantially Equivalent |
| K955369 | MEMFIX | Jan 23, 1996 | Substantially Equivalent |
| K941393 | ITI ANGLED ABUTMENT | Jun 14, 1995 | Substantially Equivalent |
| K943720 | ITI TRANSVERSAL SCREWING SYSTEM | Mar 24, 1995 | Substantially Equivalent |