HYDRORISE AND HYDROSYSTEM— 510(k) K083739
Substantially EquivalentZhermack S.P.A.
FDA 510(k) clearance K083739 for HYDRORISE AND HYDROSYSTEM, Substantially Equivalent on 2009-03-26. Applicant: Zhermack S.P.A.. Device class: 2.
Clearance details
- Applicant
- Zhermack S.P.A.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bend, OR, US
Recent devices under product code ELW
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- K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
- K241924 — Elastic Impression Material
- K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
More clearances from Zhermack S.P.A.
view allRecalls naming K083739
K-number listed on FDA's recall record- Z-0717-2017 — Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
- Z-0718-2017 — Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
- Z-0719-2017 — Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083739.
Data sourced from openFDA. This site is unofficial and independent of the FDA.