Disposable Periodontal Probe

FDA 510(k) K871504 · Periodontal Health Brush, Inc.

Substantially Equivalent

510(k) numberK871504

Submission

Device name
Disposable Periodontal Probe
Applicant
Periodontal Health Brush, Inc.
Osseo, WI, US
Received
April 17, 1987
Decision date
May 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EIX – Probe, Periodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EIX

510(k)DeviceApplicantDecision
K960245Vip Victor Interactive ProbeEIX · Traditional Pro-Dentec04/04/1996SE
K944848The Vivacare T.P.S. ProbeEIX · Traditional Rms Div.12/14/1994SE
K936221Probe Tip/Peri Probe/Peri Probe Comp.EIX · Traditional Pd International AB08/01/1994SE
K890333Albumin ReagentEIX · Traditional Alpkem Corp.02/17/1989SE
K880827Accutek Periodontal ProbeEIX · Traditional Sweet Micro Systems, Inc.04/12/1988SE
K875076Florida ProbeEIX · Traditional Florida Probe Corp.03/10/1988SE
K870280Accudent AccuprobeEIX · Traditional Accudent, Inc.06/08/1987SE
K823324Dental Instruments - ProbesEIX · Traditional Miltex, Inc.11/24/1982SE

Questions and answers

When was Disposable Periodontal Probe cleared by the FDA?

Disposable Periodontal Probe (K871504) received a 510(k) decision of Substantially Equivalent on May 6, 1987, 19 days after the submission was received.

What is the product code of K871504?

The FDA product code is EIX – Probe, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.