FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
K Number: K905223
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
269
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Basic Information
- Device Name
- OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
- K Number
- K905223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Universal Implant Systems, Inc.
- Date Received
- November 20, 1990
- Decision Date
- August 16, 1991
- 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 Universal Implant Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011574 | UNIPLANT DENTAL IMPLANT SYSTEM | Sep 28, 2001 | Substantially Equivalent |