VITALESCENCE— 510(k) K974282

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K974282 for VITALESCENCE, Substantially Equivalent on 1998-01-29. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1997-11-14
Decision date: 1998-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K974282

K-number listed on FDA's recall record

Z-3066-2024 — Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/AClass II·Ongoing·Ultradent Products, Inc.·20240802

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974282.

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