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FDA 510(k)

Dental Cone; Dental Sponge

K-Number: K253758 · 2025-12-18

Decision Date2025-12-18
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Dental Cone; Dental Sponge is the device name listed in this FDA 510(k) record. The listed applicant is Medizin Produkte Neustadt GmbH (Mpn). It received FDA 510(k) clearance on 2025-12-18 under 510(k) 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. The listed applicant is Medizin Produkte Neustadt GmbH (Mpn). The 510(k) number is K253758.

When did Dental Cone; Dental Sponge receive FDA 510(k) clearance?

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

Who is the listed applicant for Dental Cone; Dental Sponge?

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

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

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

Related Devices (Code: OLR)

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.

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.