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FDA 510(k)

DENTA PLAST

K-Number: K830440 · 1983-04-28

ApplicantDenta, Inc.
Decision Date1983-04-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTA PLAST is the device name listed in this FDA 510(k) record. The listed applicant is Denta, Inc.. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K830440. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTA PLAST?

DENTA PLAST is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is Denta, Inc.. The 510(k) number is K830440.

When did DENTA PLAST receive FDA 510(k) clearance?

DENTA PLAST received FDA 510(k) clearance on 1983-04-28, under 510(k) number K830440.

Who is the listed applicant for DENTA PLAST?

The FDA 510(k) record lists Denta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTA PLAST?

The FDA product code for DENTA PLAST is EMA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Denta, Inc. 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.

K830439DENTA A-33

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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