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FDA 510(k)

DENTAPLAST HOT, MODEL 16-XXX

K-Number: K052780 · 2005-12-21

ApplicantBredent-Products For the Dental Technician Laborat
Decision Date2005-12-21
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAPLAST HOT, MODEL 16-XXX is the device name listed in this FDA 510(k) record. The listed applicant is Bredent-Products For the Dental Technician Laborat. It received FDA 510(k) clearance on 2005-12-21 under 510(k) number K052780. 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 DENTAPLAST HOT, MODEL 16-XXX?

DENTAPLAST HOT, MODEL 16-XXX is a medical device that received FDA 510(k) clearance on 2005-12-21. The listed applicant is Bredent-Products For the Dental Technician Laborat. The 510(k) number is K052780.

When did DENTAPLAST HOT, MODEL 16-XXX receive FDA 510(k) clearance?

DENTAPLAST HOT, MODEL 16-XXX received FDA 510(k) clearance on 2005-12-21, under 510(k) number K052780.

Who is the listed applicant for DENTAPLAST HOT, MODEL 16-XXX?

The FDA 510(k) record lists Bredent-Products For the Dental Technician Laborat as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAPLAST HOT, MODEL 16-XXX?

The FDA product code for DENTAPLAST HOT, MODEL 16-XXX is EBI.

Related Clinical Trials

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.

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Other records listing Bredent-Products For the Dental Technician Laborat 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.

K052779BRECOMPK052781BREFORMANCE

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.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.

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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