Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K232498 · 2023-08-18

ApplicantUltradent Product, Inc.
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 a medical device manufactured by Ultradent Product, Inc.. It received FDA 510(k) clearance on 2023-08-18 under approval 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. It is manufactured by Ultradent Product, Inc.. The 510(k) number is K232498.

When was UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio approved by the FDA?

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

What company makes 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 manufactured by Ultradent Product, Inc..

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 Devices by Ultradent Product, Inc.

K201795Transcend

Related Devices (Code: EBC)

K161580Premier SealantPremier Dental Company Products K171330Nanova SealantNanova Biomaterials, Inc. K162598HAPI SealBisco, Inc. K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation K190998BA Pit & Fissure SealantApex Dental Materials, Inc. K190339Helioseal F PlusIvoclar Vivadent, AG

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.

↑