FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXITIME FLOW
K Number: K091494
·
Decision Jul 31, 2009
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
145
Review Days
72
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Basic Information
- Device Name
- FLEXITIME FLOW
- K Number
- K091494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- May 20, 2009
- Decision Date
- July 31, 2009
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Heraeus Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |
| K033628 | ARTIC | Jan 16, 2004 | Substantially Equivalent |