FDA 510(k)

JET SET 4 DENTURE REPAIR RESIN

Numéro K : K152981 · 2016-09-02

DemandeurLang Dental Manufacturing Company, Inc.

Date de décision2016-09-02

Code produitEBI

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

JET SET 4 DENTURE REPAIR RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Company, Inc.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K152981. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the JET SET 4 DENTURE REPAIR RESIN?

JET SET 4 DENTURE REPAIR RESIN is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Lang Dental Manufacturing Company, Inc.. The 510(k) number is K152981.

When did JET SET 4 DENTURE REPAIR RESIN receive FDA 510(k) clearance?

JET SET 4 DENTURE REPAIR RESIN received FDA 510(k) clearance on 2016-09-02, under 510(k) number K152981.

Who is the listed applicant for JET SET 4 DENTURE REPAIR RESIN?

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

What is the FDA product code for JET SET 4 DENTURE REPAIR RESIN?

The FDA product code for JET SET 4 DENTURE REPAIR RESIN is EBI.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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