Xantalgin Crono
FDA 510(k) K013336 · Cavex Holland BV
510(k) numberK013336
Submission
- Device name
- Xantalgin Crono
- Applicant
- Cavex Holland BV
Haarlem, NL - Received
- October 9, 2001
- Decision date
- October 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K073539 | Provisa CemEMB · Traditional | 01/31/2008SE |
| K072245 | Emulate AdvancedELW · Traditional | 11/08/2007SE |
| K062400 | Impressix, Colorchange AlginateELW · Traditional | 11/16/2006SE |
| K061267 | Simulate, Color Change AlginateELW · Traditional | 07/10/2006SE |
| K052455 | ImpressixELW · Traditional | 11/23/2005SE |
| K051207 | Cavex OrthotraceELW · Traditional | 06/21/2005SE |
| K042806 | Quadrant UNIT-1-BONDKLE · Traditional | 11/24/2004SE |
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Questions and answers
When was Xantalgin Crono cleared by the FDA?
Xantalgin Crono (K013336) received a 510(k) decision of Substantially Equivalent on October 29, 2001, 20 days after the submission was received.
What is the product code of K013336?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.