FDA 510(k)

DDS-ZR

K-Number: K041645 · 2004-07-09

Decision Date2004-07-09

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DDS-ZR is the device name listed in this FDA 510(k) record. The listed applicant is Charles Scharf. It received FDA 510(k) clearance on 2004-07-09 under 510(k) number K041645. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDS-ZR?

DDS-ZR is a medical device that received FDA 510(k) clearance on 2004-07-09. The listed applicant is Charles Scharf. The 510(k) number is K041645.

When did DDS-ZR receive FDA 510(k) clearance?

DDS-ZR received FDA 510(k) clearance on 2004-07-09, under 510(k) number K041645.

Who is the listed applicant for DDS-ZR?

The FDA 510(k) record lists Charles Scharf as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DDS-ZR?

The FDA product code for DDS-ZR is EIH.

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.

Official Source

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