ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)— 510(k) K972027
Substantially EquivalentZhermack S.P.A.
FDA 510(k) clearance K972027 for ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,), Substantially Equivalent on 1997-07-16. 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
- St Louis, MO, US
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More clearances from Zhermack S.P.A.
view allRecalls naming K972027
K-number listed on FDA's recall record- Z-0811-2013 — Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
- Z-0812-2013 — Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.