FDA · official record K232498Substantially Equivalent

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

Name: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio — FDA K232498
Creator: Ultradent Product, Inc.
Keywords: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio, UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio, K232498, EBC, FDA

United StatesEBCUltradent Product, Inc.

Verified

Official record identity

FDA application number: K232498
Decision date: August 18, 2023
Published decision: Substantially Equivalent

Classification

Product code: EBC

Published parties

Applicant: Ultradent Product, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2023-08-17
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3765

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.