Hydrorise and Hydrosystem
FDA 510(k) K083739 · Zhermack S.P.A.
510(k) numberK083739
Submission
- Device name
- Hydrorise and Hydrosystem
- Applicant
- Zhermack S.P.A.
Bend, OR, US - Received
- December 16, 2008
- Decision date
- March 26, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K070677 | ColoriseELW · Traditional | 05/11/2007SE |
| K070700 | FreealginELW · Traditional | 04/25/2007SE |
| K053619 | ColorbiteELW · Traditional | 03/01/2006SE |
| K050417 | Elite ImplantELW · Traditional | 07/19/2005SE |
| K051424 | Hydrogum 5ELW · Traditional | 07/15/2005SE |
| K043118 | Hydrogum SoftELW · Traditional | 01/24/2005SE |
| K043131 | TorpicalginELW · Traditional | 12/15/2004SE |
Questions and answers
When was Hydrorise and Hydrosystem cleared by the FDA?
Hydrorise and Hydrosystem (K083739) received a 510(k) decision of Substantially Equivalent on March 26, 2009, 100 days after the submission was received.
What is the product code of K083739?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.