FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
K Number: K922872
·
Decision Jul 25, 1994
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
25
Review Days
770
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Basic Information
- Device Name
- INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
- K Number
- K922872
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Interpore Intl.
- Date Received
- June 15, 1992
- Decision Date
- July 25, 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 Interpore Intl.
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|---|---|---|---|
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| K972842 | INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE | Oct 30, 1997 | Substantially Equivalent |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Jun 3, 1997 | Substantially Equivalent |
| K960945 | IMZ MEMBRANE TACK SYSTEM | May 24, 1996 | Substantially Equivalent |
| K960371 | INTERPORE THREADED IMPLANT | Mar 8, 1996 | Substantially Equivalent |
| K955492 | INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT | Jan 30, 1996 | Substantially Equivalent |
| K952167 | IMZ BONE TACK SYSTEM | Nov 21, 1995 | Substantially Equivalent |
| K950165 | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS | Mar 28, 1995 | Substantially Equivalent |
| K922732 | INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER | Feb 10, 1994 | Substantially Equivalent |