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Luxene Vinyl-Ject 3600-80

by Howmedica Corp.

510(k) K834046

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 NumberK834046 Date3 Feb 1984ClearedStatusActive

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  • Withdrawn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
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Luxene Vinyl-Ject 3600-80 is a Class 2 Dental device with product code EBF. It is substantially equivalent to a predicate device cleared through the Traditional 510(k) pathway.

The device was manufactured by Howmedica Corp. and received FDA 510(k) clearance under number K834046 on February 3, 1984, following a submission received on November 23, 1983. It is regulated as a Dental device under the DE advisory committee.

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Questions

AI-generated answers, 24 Sep 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 Luxene Vinyl-Ject 3600-80 used for?

    The Luxene Vinyl-Ject 3600-80 is a Class 2 Dental device designed for dental applications, as indicated by its product code EBF and regulation under the Dental advisory committee (DE). It was cleared as substantially equivalent to a predicate device for dental use.

  • How was the Luxene Vinyl-Ject 3600-80 cleared for market?

    The device received FDA 510(k) clearance through the Traditional pathway under number K834046, following a submission received on November 23, 1983, and a decision date of February 3, 1984, based on substantial equivalence to a predicate device.

  • Who manufactures the Luxene Vinyl-Ject 3600-80 and where is it located?

    The Luxene Vinyl-Ject 3600-80 is manufactured by Howmedica Corp., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as specified in the device’s authorization and address details.