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FDA 510(k)

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA

K-Number: K994376 · 2000-03-24

ApplicantFriadent GmbH
Decision Date2000-03-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA is the device name listed in this FDA 510(k) record. The listed applicant is Friadent GmbH. It received FDA 510(k) clearance on 2000-03-24 under 510(k) number K994376. 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 FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA?

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA is a medical device that received FDA 510(k) clearance on 2000-03-24. The listed applicant is Friadent GmbH. The 510(k) number is K994376.

When did FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA receive FDA 510(k) clearance?

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA received FDA 510(k) clearance on 2000-03-24, under 510(k) number K994376.

Who is the listed applicant for FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA?

The FDA 510(k) record lists Friadent GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA?

The FDA product code for FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA is DZE.

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Other records listing Friadent GmbH 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.

K040170FRIADENT PLUS DENTAL IMPLANT SYSTEMSK041509ANKYLOS DENTAL IMPLANT SYSTEMK040946ANKYLOS DENTAL IMPLANT SYSTEMK032302XIVE TG ABUTMENTSK032284XIVE TG DENTAL IMPLANT SYSTEMK032158XIVE DENTAL IMPLANT SYSTEM MULTIPLE

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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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