FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERACERAM PRESS
K Number: K040859
·
Decision May 20, 2004
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
145
Review Days
48
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Basic Information
- Device Name
- HERACERAM PRESS
- K Number
- K040859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- April 2, 2004
- Decision Date
- May 20, 2004
- 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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| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |
| K033628 | ARTIC | Jan 16, 2004 | Substantially Equivalent |