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FDA 510(k)

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio

K-Number: K232498 · 2023-08-18

Decision Date2023-08-18
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Product, Inc.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K232498. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio?

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Ultradent Product, Inc.. The 510(k) number is K232498.

When did UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio receive FDA 510(k) clearance?

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232498.

Who is the listed applicant for UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio?

The FDA 510(k) record lists Ultradent Product, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio?

The FDA product code for UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio is EBC.

Other records listing Ultradent Product, Inc. 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.

Related Devices (Code: EBC)

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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