Probe Tip/Peri Probe/Peri Probe Comp.

FDA 510(k) K936221 · Pd International AB

Substantially Equivalent

510(k) numberK936221

Submission

Device name
Probe Tip/Peri Probe/Peri Probe Comp.
Applicant
Pd International AB
Sloane, SE
Received
December 27, 1993
Decision date
August 1, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K871504Disposable Periodontal ProbeEIX · Traditional Periodontal Health Brush, Inc.05/06/1987SE
K823324Dental Instruments - ProbesEIX · Traditional Miltex, Inc.11/24/1982SE

Questions and answers

When was Probe Tip/Peri Probe/Peri Probe Comp. cleared by the FDA?

Probe Tip/Peri Probe/Peri Probe Comp. (K936221) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 217 days after the submission was received.

What is the product code of K936221?

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