FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-BOND HI-LIFE PROCELAIN & VIVERE
K Number: K802235
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
373
Review Days
11
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Basic Information
- Device Name
- MICRO-BOND HI-LIFE PROCELAIN & VIVERE
- K Number
- K802235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- September 15, 1980
- Decision Date
- September 26, 1980
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
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| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
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| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
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