FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMEDIATE STABILIZING IMPLANT (ISI)
K Number: K033392
·
Decision Dec 10, 2003
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
17
Review Days
48
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Basic Information
- Device Name
- IMMEDIATE STABILIZING IMPLANT (ISI)
- K Number
- K033392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O Co., Inc.
- Date Received
- October 23, 2003
- Decision Date
- December 10, 2003
- 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 O Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023336 | OCO DENTAL IMPLANT (5.0MM DIAMETER) | Oct 9, 2002 | Substantially Equivalent |
| K021460 | OCO DENTAL IMPLANT | May 22, 2002 | Substantially Equivalent |
| K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | Apr 10, 2002 | Substantially Equivalent |
| K010142 | OCO DENTAL IMPLANT | Feb 1, 2001 | Substantially Equivalent |
| K973926 | O BUTMENT HS IMPLANT | Jan 5, 1998 | Substantially Equivalent |
| K961665 | O BUTMENT ET IMPLANT | Nov 15, 1996 | Substantially Equivalent |
| K950066 | DENTAL IMPLANT ENDOSSEOUS | Sep 15, 1995 | Substantially Equivalent |
| K946113 | IMPLANT BODY RETRIEVER/REMOVER | Mar 1, 1995 | Substantially Equivalent |
| K946129 | IMPLANT BODY DEPTH GAUGE/TRYIN | Mar 1, 1995 | Substantially Equivalent |
| K945300 | ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT | Feb 16, 1995 | Substantially Equivalent |