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FDA 510(k)

QUANTUM DENTAL IMPLANT SYSTEM

K-Number: K112279 · 2012-05-04

ApplicantQuantum Bioengineering, Ltd.
Decision Date2012-05-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUANTUM DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Bioengineering, Ltd.. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K112279. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM DENTAL IMPLANT SYSTEM?

QUANTUM DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is Quantum Bioengineering, Ltd.. The 510(k) number is K112279.

When did QUANTUM DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

QUANTUM DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2012-05-04, under 510(k) number K112279.

Who is the listed applicant for QUANTUM DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for QUANTUM DENTAL IMPLANT SYSTEM?

The FDA product code for QUANTUM DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

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Other records listing Quantum Bioengineering, Ltd. 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.

K130787QUANTUM DENTAL IMPLANT SYSTEMK002241QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEMK991250QUANTUM VERSATILITY IMPLANT SYSTEM

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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