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FDA 510(k)

SPI ONETIME DENTAL IMPLANT

K-Number: K022038 · 2002-07-15

ApplicantPaxmed International
Decision Date2002-07-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPI ONETIME DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Paxmed International. It received FDA 510(k) clearance on 2002-07-15 under 510(k) number K022038. 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 SPI ONETIME DENTAL IMPLANT?

SPI ONETIME DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2002-07-15. The listed applicant is Paxmed International. The 510(k) number is K022038.

When did SPI ONETIME DENTAL IMPLANT receive FDA 510(k) clearance?

SPI ONETIME DENTAL IMPLANT received FDA 510(k) clearance on 2002-07-15, under 510(k) number K022038.

Who is the listed applicant for SPI ONETIME DENTAL IMPLANT?

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 SPI ONETIME DENTAL IMPLANT?

The FDA product code for SPI ONETIME DENTAL IMPLANT 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-FILLAPEXK010467UNIVERSAL DENTAL COPING (UDC)K011223QUANTUM VERSATILITY (QVS) DENTAL 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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