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FDA 510(k)

VERSAETCH

K-Number: K973257 · 1997-11-17

ApplicantCentrix, Inc.
Decision Date1997-11-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERSAETCH is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1997-11-17 under 510(k) number K973257. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAETCH?

VERSAETCH is a medical device that received FDA 510(k) clearance on 1997-11-17. The listed applicant is Centrix, Inc.. The 510(k) number is K973257.

When did VERSAETCH receive FDA 510(k) clearance?

VERSAETCH received FDA 510(k) clearance on 1997-11-17, under 510(k) number K973257.

Who is the listed applicant for VERSAETCH?

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

What is the FDA product code for VERSAETCH?

The FDA product code for VERSAETCH is EBF.

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Other records listing Centrix, 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.

K250714FluoroDose VarnishK222459Centrix FluoroSilver Silver Diamine Fluoride 38%K152826NoCordK120176SENZZZZZ AWAYK111348RE / STASIS (TM) GINGIVAL RETRACTION PASTEK092384LIQUICORD

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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