Skip to content

Point 4 Modified

by Sybron Dental Specialties, Inc.

510(k) K013510

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

Overview

The POINT 4 MODIFIED dental implant system is a cutting-edge, modified version of the original design, engineered with enhanced features to deliver superior performance and durability. Developed with advancements in materials science and innovative manufacturing techniques, this device offers improved precision, stability, and aesthetic outcomes for patients seeking a more reliable and successful treatment.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013510 Date18 Jan 2002ClearedStatusActive

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  • Withdrawn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

Other devices from Sybron Dental Specialties, Inc.

  • Prodigy 4

    Class II

  • Kerr Gel Etchant

    Class II

  • Sealapex 4

    Class II

  • Point 4 Flowable

    Class II

  • Temp-Bond Ne 2

    Class II

  • Extrude

    Class II

See all devices from Sybron Dental Specialties, Inc. →