ULTRASEAL XT PLUS— 510(k) K993846

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K993846 for ULTRASEAL XT PLUS, Substantially Equivalent on 2000-02-16. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1999-11-12
Decision date: 2000-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K993846

K-number listed on FDA's recall record

Z-0704-2017 — UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.Class II·Terminated·Ultradent Products, Inc.·20161117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993846.

Data sourced from openFDA. This site is unofficial and independent of the FDA.