Aukusleeve

FDA 510(k) K930094 · Aukland Medical Plastics, Inc.

Substantially Equivalent

510(k) numberK930094

Submission

Device name
Aukusleeve
Applicant
Aukland Medical Plastics, Inc.
Cary, NC, US
Received
January 8, 1993
Decision date
October 20, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJB – Handle, Instrument, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EJB

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K140144Benda WedgeEJB · Traditional Centrix, Inc.07/08/2014SE
K023367Detectar, Model N123-MIEJB · Traditional Neks Technologies06/25/2003SE
K981234Flare,File, FillEJB · Traditional Lone Star Technologies06/05/1998SE
K922633Cavi-ZymeEJB · Traditional E&D Dental Products, Inc.08/06/1992SE
K871818Spatula, Dental, CementEJB · Traditional Military Engineering, Inc.07/02/1987SE
K833338Tooth SloothEJB · Traditional Joel Lander D.D.S.11/25/1983SE
K823913Soft Grip Uni-HandleEJB · Traditional Treace Medical, Inc.01/26/1983SE

More from Treace Medical, Inc.

510(k)DeviceDecision
K953610AukulyteKPY · Traditional 09/26/1995SE
K930840Post-Myds(Tm)HOY · Traditional 03/01/1994SE

Questions and answers

When was Aukusleeve cleared by the FDA?

Aukusleeve (K930094) received a 510(k) decision of Substantially Equivalent on October 20, 1993, 285 days after the submission was received.

What is the product code of K930094?

The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.