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FDA 510(k)

PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT

K-Number: K082560 · 2008-09-08

ApplicantKettenbach GmbH & Co. KG
Decision Date2008-09-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2008-09-08 under 510(k) number K082560. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT?

PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT is a medical device that received FDA 510(k) clearance on 2008-09-08. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K082560.

When did PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT receive FDA 510(k) clearance?

PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT received FDA 510(k) clearance on 2008-09-08, under 510(k) number K082560.

Who is the listed applicant for PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT?

The FDA 510(k) record lists Kettenbach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT?

The FDA product code for PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT is ELW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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