FDA 510(k)

EDTA GEL (TM)

K-Number: K940737 · 1994-06-03

Decision Date1994-06-03

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EDTA GEL (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Karolinska Institutet. It received FDA 510(k) clearance on 1994-06-03 under 510(k) number K940737. 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 EDTA GEL (TM)?

EDTA GEL (TM) is a medical device that received FDA 510(k) clearance on 1994-06-03. The listed applicant is Karolinska Institutet. The 510(k) number is K940737.

When did EDTA GEL (TM) receive FDA 510(k) clearance?

EDTA GEL (TM) received FDA 510(k) clearance on 1994-06-03, under 510(k) number K940737.

Who is the listed applicant for EDTA GEL (TM)?

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

What is the FDA product code for EDTA GEL (TM)?

The FDA product code for EDTA GEL (TM) is EBF.

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

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