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FDA 510(k)

SpiralTech Dental Implant System

K-Number: K170372 · 2017-06-30

ApplicantSpiraltech Superior Dental Implants, Inc.
Decision Date2017-06-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SpiralTech Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Spiraltech Superior Dental Implants, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K170372. 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 SpiralTech Dental Implant System?

SpiralTech Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Spiraltech Superior Dental Implants, Inc.. The 510(k) number is K170372.

When did SpiralTech Dental Implant System receive FDA 510(k) clearance?

SpiralTech Dental Implant System received FDA 510(k) clearance on 2017-06-30, under 510(k) number K170372.

Who is the listed applicant for SpiralTech Dental Implant System?

The FDA 510(k) record lists Spiraltech Superior Dental Implants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpiralTech Dental Implant System?

The FDA product code for SpiralTech Dental Implant System is DZE.

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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