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FDA 510(k)

LEONE MONOIMPLANT FOR O-RING OVERDENTURE

K-Number: K070483 · 2007-04-19

ApplicantLeone S.P.A.
Decision Date2007-04-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEONE MONOIMPLANT FOR O-RING OVERDENTURE is the device name listed in this FDA 510(k) record. The listed applicant is Leone S.P.A.. It received FDA 510(k) clearance on 2007-04-19 under 510(k) number K070483. 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 LEONE MONOIMPLANT FOR O-RING OVERDENTURE?

LEONE MONOIMPLANT FOR O-RING OVERDENTURE is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Leone S.P.A.. The 510(k) number is K070483.

When did LEONE MONOIMPLANT FOR O-RING OVERDENTURE receive FDA 510(k) clearance?

LEONE MONOIMPLANT FOR O-RING OVERDENTURE received FDA 510(k) clearance on 2007-04-19, under 510(k) number K070483.

Who is the listed applicant for LEONE MONOIMPLANT FOR O-RING OVERDENTURE?

The FDA 510(k) record lists Leone S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEONE MONOIMPLANT FOR O-RING OVERDENTURE?

The FDA product code for LEONE MONOIMPLANT FOR O-RING OVERDENTURE 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 Leone S.P.A. 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.

K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)K071490LEONE ORTHODONTIC MINI IMPLANTK050586LEONE 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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