Tulip Colorswitch
FDA 510(k) K032116 · Cavex Holland BV
510(k) numberK032116
Submission
- Device name
- Tulip Colorswitch
- Applicant
- Cavex Holland BV
Haarlem, NL - Received
- July 9, 2003
- Decision date
- September 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
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| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| 510(k) | Device | Decision |
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| K151535 | Cavex Cream AlginateELW · Traditional | 10/28/2015SE |
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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 |
| K023466 | Tulip Alginate Impression MaterialELW · Traditional | 12/13/2002SE |
Questions and answers
When was Tulip Colorswitch cleared by the FDA?
Tulip Colorswitch (K032116) received a 510(k) decision of Substantially Equivalent on September 30, 2003, 83 days after the submission was received.
What is the product code of K032116?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.