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FDA 510(k)

MIRAGE COMPLETE KIT AND MIRAGE ABC KIT

K-Number: K915511 · 1992-03-06

ApplicantMirage Dental Systems
Decision Date1992-03-06
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRAGE COMPLETE KIT AND MIRAGE ABC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mirage Dental Systems. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K915511. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRAGE COMPLETE KIT AND MIRAGE ABC KIT?

MIRAGE COMPLETE KIT AND MIRAGE ABC KIT is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is Mirage Dental Systems. The 510(k) number is K915511.

When did MIRAGE COMPLETE KIT AND MIRAGE ABC KIT receive FDA 510(k) clearance?

MIRAGE COMPLETE KIT AND MIRAGE ABC KIT received FDA 510(k) clearance on 1992-03-06, under 510(k) number K915511.

Who is the listed applicant for MIRAGE COMPLETE KIT AND MIRAGE ABC KIT?

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

What is the FDA product code for MIRAGE COMPLETE KIT AND MIRAGE ABC KIT?

The FDA product code for MIRAGE COMPLETE KIT AND MIRAGE ABC KIT is KLE.

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 Mirage Dental Systems 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.

K931845SANDBLASTERK923895QUIKSEAL

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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