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FDA 510(k)

SYSTEMP.C&B PLUS

K-Number: K042820 · 2004-12-14

ApplicantIvoclar Vivadent, Inc.
Decision Date2004-12-14
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYSTEMP.C&B PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K042820. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMP.C&B PLUS?

SYSTEMP.C&B PLUS is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K042820.

When did SYSTEMP.C&B PLUS receive FDA 510(k) clearance?

SYSTEMP.C&B PLUS received FDA 510(k) clearance on 2004-12-14, under 510(k) number K042820.

Who is the listed applicant for SYSTEMP.C&B PLUS?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEMP.C&B PLUS?

The FDA product code for SYSTEMP.C&B PLUS is EBG.

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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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