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FDA 510(k)

Dental Impression Material

K-Number: K221668 · 2022-08-08

ApplicantChemoment Materials Co.,Ltd
Decision Date2022-08-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Impression Material is a medical device manufactured by Chemoment Materials Co.,Ltd. It received FDA 510(k) clearance on 2022-08-08 under approval number K221668. 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 Dental Impression Material?

Dental Impression Material is a medical device that received FDA 510(k) clearance on 2022-08-08. It is manufactured by Chemoment Materials Co.,Ltd. The 510(k) number is K221668.

When was Dental Impression Material approved by the FDA?

Dental Impression Material received FDA 510(k) clearance on 2022-08-08, under approval number K221668.

What company makes Dental Impression Material?

Dental Impression Material is manufactured by Chemoment Materials Co.,Ltd.

What is the FDA product code for Dental Impression Material?

The FDA product code for Dental Impression Material is ELW.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants 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 NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT06533397 The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation RECRUITING

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, 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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