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FDA 510(k)

FRIALIT-2 BONE PROFILER

K-Number: K993560 · 2000-01-10

ApplicantFriadent GmbH
Decision Date2000-01-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRIALIT-2 BONE PROFILER is the device name listed in this FDA 510(k) record. The listed applicant is Friadent GmbH. It received FDA 510(k) clearance on 2000-01-10 under 510(k) number K993560. 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 BONE PROFILER?

FRIALIT-2 BONE PROFILER is a medical device that received FDA 510(k) clearance on 2000-01-10. The listed applicant is Friadent GmbH. The 510(k) number is K993560.

When did FRIALIT-2 BONE PROFILER receive FDA 510(k) clearance?

FRIALIT-2 BONE PROFILER received FDA 510(k) clearance on 2000-01-10, under 510(k) number K993560.

Who is the listed applicant for FRIALIT-2 BONE PROFILER?

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 BONE PROFILER?

The FDA product code for FRIALIT-2 BONE PROFILER 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)

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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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