FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSYO.DIRECT
K Number: K043295
·
Decision Jan 5, 2005
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
145
Review Days
37
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Basic Information
- Device Name
- VERSYO.DIRECT
- K Number
- K043295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- November 29, 2004
- Decision Date
- January 5, 2005
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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|---|---|---|---|
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| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
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| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
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| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |
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