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FDA 510(k)

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)

K-Number: K213244 · 2022-09-09

ApplicantPrevest Denpro Limited
Decision Date2022-09-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is a medical device manufactured by Prevest Denpro Limited. It received FDA 510(k) clearance on 2022-09-09 under approval number K213244. 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 Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Prevest Denpro Limited. The 510(k) number is K213244.

When was Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) approved by the FDA?

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) received FDA 510(k) clearance on 2022-09-09, under approval number K213244.

What company makes Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is manufactured by Prevest Denpro Limited.

What is the FDA product code for Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

The FDA product code for Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is ELW.

Related Clinical Trials

NCT07608211 Development of a Sanitizing Tablet for Removable Partial Dentures NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07598305 PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers COMPLETED NCT07599202 Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING

Other Devices by Prevest Denpro Limited

K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K233273C&B Ceramic; C&B Permanent; C&B Interim K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

View all 7 devices →

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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