FDA 510(k)

COE-SOFT LC

K-Number: K940565 · 1994-05-04

Decision Date1994-05-04

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

COE-SOFT LC is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1994-05-04 under 510(k) number K940565. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COE-SOFT LC?

COE-SOFT LC is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is GC America, Inc.. The 510(k) number is K940565.

When did COE-SOFT LC receive FDA 510(k) clearance?

COE-SOFT LC received FDA 510(k) clearance on 1994-05-04, under 510(k) number K940565.

Who is the listed applicant for COE-SOFT LC?

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

What is the FDA product code for COE-SOFT LC?

The FDA product code for COE-SOFT LC is EBI.

Other records listing GC America, 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.

K262202Cerasmart Forte K253317Cytrans™ Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond Universal K250953EQUIA LC ONE

View all 123 devices →

Related Devices (Code: EBI)

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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.