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FDA 510(k)

D3 CHROMA

K-Number: K042422 · 2004-11-15

ApplicantSybron Dental Specialties, Inc.
Decision Date2004-11-15
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D3 CHROMA is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 2004-11-15 under 510(k) number K042422. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D3 CHROMA?

D3 CHROMA is a medical device that received FDA 510(k) clearance on 2004-11-15. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K042422.

When did D3 CHROMA receive FDA 510(k) clearance?

D3 CHROMA received FDA 510(k) clearance on 2004-11-15, under 510(k) number K042422.

Who is the listed applicant for D3 CHROMA?

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

What is the FDA product code for D3 CHROMA?

The FDA product code for D3 CHROMA is DYH.

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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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