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FDA 510(k)

ONEPLANT DENTAL IMPLANT SYSTEM

K-Number: K081748 · 2009-03-27

ApplicantWarantec Co., Ltd.
Decision Date2009-03-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ONEPLANT DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Warantec Co., Ltd.. It received FDA 510(k) clearance on 2009-03-27 under 510(k) number K081748. 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 ONEPLANT DENTAL IMPLANT SYSTEM?

ONEPLANT DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Warantec Co., Ltd.. The 510(k) number is K081748.

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

ONEPLANT DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-03-27, under 510(k) number K081748.

Who is the listed applicant for ONEPLANT DENTAL IMPLANT SYSTEM?

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

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

The FDA product code for ONEPLANT 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 Warantec Co., 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.

K221972Warantec Custom AbutmentK221969IU Implant System AbutmentK172345IU 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

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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