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FDA 510(k)

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

K-Number: K011223 · 2001-09-20

ApplicantPaxmed International
Decision Date2001-09-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paxmed International. It received FDA 510(k) clearance on 2001-09-20 under 510(k) number K011223. 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 VERSATILITY (QVS) DENTAL IMPLANT SYSTEM?

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is Paxmed International. The 510(k) number is K011223.

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

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2001-09-20, under 510(k) number K011223.

Who is the listed applicant for QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM?

The FDA product code for QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM is DZE.

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 Paxmed International 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.

K113568MTA-FILLAPEXK022038SPI ONETIME DENTAL IMPLANTK010467UNIVERSAL DENTAL COPING (UDC)

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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