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FDA 510(k)

ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS

K-Number: K130680 · 2013-07-26

ApplicantDentsoll, Inc.
Decision Date2013-07-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsoll, Inc.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K130680. 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 ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS?

ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Dentsoll, Inc.. The 510(k) number is K130680.

When did ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS receive FDA 510(k) clearance?

ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130680.

Who is the listed applicant for ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS?

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

What is the FDA product code for ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS?

The FDA product code for ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS is EBI.

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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

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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