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FDA 510(k)

RELYX LUTING PLUS AUTOMIX

K-Number: K111185 · 2011-05-05

Applicant3M Espe Dental Products
Decision Date2011-05-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RELYX LUTING PLUS AUTOMIX is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2011-05-05 under 510(k) number K111185. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELYX LUTING PLUS AUTOMIX?

RELYX LUTING PLUS AUTOMIX is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is 3M Espe Dental Products. The 510(k) number is K111185.

When did RELYX LUTING PLUS AUTOMIX receive FDA 510(k) clearance?

RELYX LUTING PLUS AUTOMIX received FDA 510(k) clearance on 2011-05-05, under 510(k) number K111185.

Who is the listed applicant for RELYX LUTING PLUS AUTOMIX?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELYX LUTING PLUS AUTOMIX?

The FDA product code for RELYX LUTING PLUS AUTOMIX is EMA.

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Other records listing 3M Espe Dental Products 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.

K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentK2302703M™ VitCal Liner/BaseK1911223M RelyX Pediatric Resin Modified Glass Ionomer CementK1834763M Filtek Universal RestorativeK120453FILTEK BULK FILL FLOWABLE RESTORATIVEK110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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