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FDA 510(k)

IMAX 9.5 STERILIZERS

K-Number: K052532 · 2006-09-05

ApplicantDental X Srl
Decision Date2006-09-05
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMAX 9.5 STERILIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Dental X Srl. It received FDA 510(k) clearance on 2006-09-05 under 510(k) number K052532. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAX 9.5 STERILIZERS?

IMAX 9.5 STERILIZERS is a medical device that received FDA 510(k) clearance on 2006-09-05. The listed applicant is Dental X Srl. The 510(k) number is K052532.

When did IMAX 9.5 STERILIZERS receive FDA 510(k) clearance?

IMAX 9.5 STERILIZERS received FDA 510(k) clearance on 2006-09-05, under 510(k) number K052532.

Who is the listed applicant for IMAX 9.5 STERILIZERS?

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

What is the FDA product code for IMAX 9.5 STERILIZERS?

The FDA product code for IMAX 9.5 STERILIZERS is FLE.

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Related Devices (Code: FLE)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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