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FDA 510(k)

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4

K-Number: K081200 · 2008-08-08

ApplicantGlobal Top, Inc.
Decision Date2008-08-08
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 is the device name listed in this FDA 510(k) record. The listed applicant is Global Top, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081200. 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 DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4?

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Global Top, Inc.. The 510(k) number is K081200.

When did DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 receive FDA 510(k) clearance?

DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081200.

Who is the listed applicant for DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4?

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

What is the FDA product code for DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4?

The FDA product code for DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 is EIH.

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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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