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FDA 510(k)

Piccolo Implants and Accessories

K-Number: K173706 · 2018-06-08

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2018-06-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Piccolo Implants and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K173706. 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 Piccolo Implants and Accessories?

Piccolo Implants and Accessories is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K173706.

When did Piccolo Implants and Accessories receive FDA 510(k) clearance?

Piccolo Implants and Accessories received FDA 510(k) clearance on 2018-06-08, under 510(k) number K173706.

Who is the listed applicant for Piccolo Implants and Accessories?

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

What is the FDA product code for Piccolo Implants and Accessories?

The FDA product code for Piccolo Implants and Accessories is DZE.

Other records listing Southern Implants (Pty), Ltd. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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