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FDA 510(k)

Dental Cone; Dental Sponge

K-Number: K253758 · 2025-12-18

ApplicantMedizin Produkte Neustadt GmbH (Mpn)
Decision Date2025-12-18
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Dental Cone; Dental Sponge is a medical device manufactured by Medizin Produkte Neustadt GmbH (Mpn). It received FDA 510(k) clearance on 2025-12-18 under approval number K253758. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Cone; Dental Sponge?

Dental Cone; Dental Sponge is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Medizin Produkte Neustadt GmbH (Mpn). The 510(k) number is K253758.

When was Dental Cone; Dental Sponge approved by the FDA?

Dental Cone; Dental Sponge received FDA 510(k) clearance on 2025-12-18, under approval number K253758.

What company makes Dental Cone; Dental Sponge?

Dental Cone; Dental Sponge is manufactured by Medizin Produkte Neustadt GmbH (Mpn).

What is the FDA product code for Dental Cone; Dental Sponge?

The FDA product code for Dental Cone; Dental Sponge is OLR.

Related Clinical Trials

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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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