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FDA 510(k)

JET SET 4 DENTURE REPAIR RESIN

K-Number: K152981 · 2016-09-02

ApplicantLang Dental Manufacturing Company, Inc.
Decision Date2016-09-02
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Lang Dental Manufacturing Company, 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.

K163482Orthodontic Acrylic 2

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.

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.K260376Denture BaseShandong Huge Dental Material Corporation

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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