FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM
K Number: K921854
·
Decision Oct 27, 1992
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
5
Review Days
193
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Basic Information
- Device Name
- IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM
- K Number
- K921854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impla-Med
- Date Received
- April 17, 1992
- Decision Date
- October 27, 1992
- 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 Impla-Med
| K Number | Device Name | ||
|---|---|---|---|
| K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | Sep 6, 1990 | Substantially Equivalent |
| K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | Aug 9, 1990 | Substantially Equivalent |
| K900061 | IMPLA-MED TITANIUM, IMPLANT DEVICES | Apr 27, 1990 | Substantially Equivalent |
| K892124 | IMPLA-MED IMPLANT SYSTEM | Oct 20, 1989 | Substantially Equivalent |