Accutek Periodontal Probe

FDA 510(k) K880827 · Sweet Micro Systems, Inc.

Substantially Equivalent

510(k) numberK880827

Submission

Device name
Accutek Periodontal Probe
Applicant
Sweet Micro Systems, Inc.
Cranston, RI, US
Received
March 1, 1988
Decision date
April 12, 1988
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
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 Accutek Periodontal Probe cleared by the FDA?

Accutek Periodontal Probe (K880827) received a 510(k) decision of Substantially Equivalent on April 12, 1988, 42 days after the submission was received.

What is the product code of K880827?

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