FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSSOUS IMPLANTS
K Number: K021322
·
Decision Jul 24, 2002
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- ENDOSSOUS IMPLANTS
- K Number
- K021322
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intra-Lock International
- Date Received
- April 25, 2002
- Decision Date
- July 24, 2002
- 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 Intra-Lock International
| K Number | Device Name | ||
|---|---|---|---|
| K130140 | INTRA-LOCK OP DENTAL IMPLANT | Aug 1, 2013 | Substantially Equivalent |
| K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | May 21, 2008 | Substantially Equivalent |
| K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | Oct 12, 2007 | Substantially Equivalent |
| K050970 | MILO DENTAL IMPLANT SYSTEM | Oct 14, 2005 | Substantially Equivalent |
| K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | Mar 22, 2004 | Substantially Equivalent |
| K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS | Dec 23, 2003 | Substantially Equivalent |
| K021915 | TRANSITIONAL IMPLANTS | Dec 19, 2002 | Substantially Equivalent |