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FDA 510(k)

THE.R.MO.FREE

K-Number: K990448 · 1999-03-23

ApplicantDentamax, Inc.
Decision Date1999-03-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE.R.MO.FREE is the device name listed in this FDA 510(k) record. The listed applicant is Dentamax, Inc.. It received FDA 510(k) clearance on 1999-03-23 under 510(k) number K990448. 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 THE.R.MO.FREE?

THE.R.MO.FREE is a medical device that received FDA 510(k) clearance on 1999-03-23. The listed applicant is Dentamax, Inc.. The 510(k) number is K990448.

When did THE.R.MO.FREE receive FDA 510(k) clearance?

THE.R.MO.FREE received FDA 510(k) clearance on 1999-03-23, under 510(k) number K990448.

Who is the listed applicant for THE.R.MO.FREE?

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

What is the FDA product code for THE.R.MO.FREE?

The FDA product code for THE.R.MO.FREE is EBI.

Other records listing Dentamax, 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.

K983558ACETAL DENTAL/PREFORMED CLASP

Related Devices (Code: EBI)

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.

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

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

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