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)

Identic and KromaFaze Alginate Dental Impression Materials

K-Number: K160441 · 2016-06-30

ApplicantKerr Corporation
Decision Date2016-06-30
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Identic and KromaFaze Alginate Dental Impression Materials is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2016-06-30 under approval number K160441. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Identic and KromaFaze Alginate Dental Impression Materials?

Identic and KromaFaze Alginate Dental Impression Materials is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Kerr Corporation. The 510(k) number is K160441.

When was Identic and KromaFaze Alginate Dental Impression Materials approved by the FDA?

Identic and KromaFaze Alginate Dental Impression Materials received FDA 510(k) clearance on 2016-06-30, under approval number K160441.

What company makes Identic and KromaFaze Alginate Dental Impression Materials?

Identic and KromaFaze Alginate Dental Impression Materials is manufactured by Kerr Corporation.

What is the FDA product code for Identic and KromaFaze Alginate Dental Impression Materials?

The FDA product code for Identic and KromaFaze Alginate Dental Impression Materials is ELW.

Related Clinical Trials

NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07569237 Patient-Reported Outcomes of Four Intraoral Suture Materials NOT_YET_RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT07566533 Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use COMPLETED

Other Devices by Kerr Corporation

K162436EndoVac Pure K162257P1145 Dental Restorative K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials K163064Demi Ultra K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

View all 12 devices →

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, Inc. K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, 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.

↑