Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cercon

K-Number: K162888 · 2017-02-24

ApplicantDentsply Sirona
Decision Date2017-02-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cercon is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162888. 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 Cercon?

Cercon is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Dentsply Sirona. The 510(k) number is K162888.

When did Cercon receive FDA 510(k) clearance?

Cercon received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162888.

Who is the listed applicant for Cercon?

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

What is the FDA product code for Cercon?

The FDA product code for Cercon is EIH.

Other records listing Dentsply Sirona as applicant

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.

K260785DS Core CBCT AnatomyK260722SureSmile Aligner (ASSY500020)K253565SureSmile SoftwareK251614Stainless Steel Surgical KitsK253959Primevision 3DK253009DS Core Detect

View all 86 devices →

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

↑