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SLED Curing Light System

by Dentsply International

510(k) K031615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031615 Date21 Jul 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 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  • Withdrawn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
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 SLED Curing Light System is a dental activator, ultraviolet, for polymerization device. It is classified as a class II medical device under regulation number 872.6070 with product code EBZ.

The device received FDA 510(k) clearance (K031615) on July 21, 2003, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Dentsply International.

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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 SLED Curing Light System used for?

    The SLED Curing Light System is a dental activator ultraviolet device designed for polymerization of dental materials, as specified in its FDA 510(k) clearance documentation.

  • How is the SLED Curing Light System supplied and is it reusable?

    The device data does not specify supply format or reusability; therefore, details about whether it is single-use or reusable, or how it is packaged, cannot be determined from the provided information.

  • What regulatory pathway was used for the SLED Curing Light System?

    The SLED Curing Light System received FDA 510(k) clearance through a traditional review process, as stated in the authorization and decision description fields.