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Pencure, Model VL-7

by J. Morita U.S.A., Inc

510(k) K063529

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063529 Date5 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EBZ
FDA applicant
J. Morita USA, Inc.
Device class
Class II
Regulation
21 CFR Part 872.6070
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pencure, Model VL-7 is an Activator, Ultraviolet, For Polymerization device intended for dental use. It is designed to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from the head.

This device is supplied as a reusable unit and is regulated under FDA 510(k) clearance K063529, with product code EBZ and regulation number 872.6070. It is classified as a Class II medical device and was determined to be substantially equivalent to the predicate device Jetlite5000.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Pencure VL-7 used for?

    The Pencure VL-7 is an ultraviolet activator intended for dental use to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by emitting light from its head, enabling proper curing of these materials during dental procedures.

  • Is the Pencure VL-7 reusable or single-use?

    The Pencure VL-7 is supplied as a reusable unit, meaning it can be used multiple times after appropriate cleaning and maintenance, as indicated in its device description and regulatory documentation.

  • What regulatory pathway was used for the Pencure VL-7?

    The Pencure VL-7 received FDA 510(k) clearance under number K063529, demonstrating substantial equivalence to the predicate device Jetlite5000, and is regulated as a Class II medical device under product code EBZ and regulation number 872.6070.