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FDA 510(k)

UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT

K-Number: K080162 · 2008-04-22

ApplicantMis Implants Technologies , Ltd.
Decision Date2008-04-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2008-04-22 under 510(k) number K080162. 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 UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT?

UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K080162.

When did UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT receive FDA 510(k) clearance?

UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT received FDA 510(k) clearance on 2008-04-22, under 510(k) number K080162.

Who is the listed applicant for UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT?

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

What is the FDA product code for UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT?

The FDA product code for UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT is DZE.

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Other records listing Mis Implants Technologies , 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.

K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsK180282MIS Internal Hex Dental Implant SystemK173326MIS CONNECT Conical Connection AbutmentK172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection AbutmentsK163349MIS V3 Conical Connection Dental Implant System­K112162CONICAL CONNECTION IMPLANTS

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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.

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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