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FDA 510(k)

NEW STETIC ARTIFICIAL TEETH

K-Number: K122925 · 2013-02-12

ApplicantNew Stetic
Decision Date2013-02-12
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW STETIC ARTIFICIAL TEETH is the device name listed in this FDA 510(k) record. The listed applicant is New Stetic. It received FDA 510(k) clearance on 2013-02-12 under 510(k) number K122925. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW STETIC ARTIFICIAL TEETH?

NEW STETIC ARTIFICIAL TEETH is a medical device that received FDA 510(k) clearance on 2013-02-12. The listed applicant is New Stetic. The 510(k) number is K122925.

When did NEW STETIC ARTIFICIAL TEETH receive FDA 510(k) clearance?

NEW STETIC ARTIFICIAL TEETH received FDA 510(k) clearance on 2013-02-12, under 510(k) number K122925.

Who is the listed applicant for NEW STETIC ARTIFICIAL TEETH?

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

What is the FDA product code for NEW STETIC ARTIFICIAL TEETH?

The FDA product code for NEW STETIC ARTIFICIAL TEETH is ELM.

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 New Stetic 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.

K102874NEW STETIC ACRYLICS

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AGK113426VERACIA SAShofu Dental Corporation

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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