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FDA 510(k)

SYMBIOCERAM

K-Number: K990629 · 1999-03-19

ApplicantNey Dental, Inc.
Decision Date1999-03-19
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYMBIOCERAM is the device name listed in this FDA 510(k) record. The listed applicant is Ney Dental, Inc.. It received FDA 510(k) clearance on 1999-03-19 under 510(k) number K990629. 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 SYMBIOCERAM?

SYMBIOCERAM is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Ney Dental, Inc.. The 510(k) number is K990629.

When did SYMBIOCERAM receive FDA 510(k) clearance?

SYMBIOCERAM received FDA 510(k) clearance on 1999-03-19, under 510(k) number K990629.

Who is the listed applicant for SYMBIOCERAM?

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

What is the FDA product code for SYMBIOCERAM?

The FDA product code for SYMBIOCERAM is EIH.

Related Clinical Trials

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.

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Other records listing Ney Dental, Inc. 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.

K984427EXCELSIOR PORCELAIN SYSTEM

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 DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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