Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Lang Dental Manufacturing Company, Inc.. It received FDA 510(k) clearance on 2016-09-02 under approval 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. It is manufactured by Lang Dental Manufacturing Company, Inc.. The 510(k) number is K152981.

When was JET SET 4 DENTURE REPAIR RESIN approved by the FDA?

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

What company makes JET SET 4 DENTURE REPAIR RESIN?

JET SET 4 DENTURE REPAIR RESIN is manufactured by Lang Dental Manufacturing Company, Inc..

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.

Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries K153253GC Reline IIGC America, 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.

↑