Bioloy

FDA 510(k) K023477 · Neirynck & Vogt NV

Substantially Equivalent

510(k) numberK023477

Submission

Device name
Bioloy
Applicant
Neirynck & Vogt NV
Pickerington, OH, US
Received
October 16, 2002
Decision date
December 13, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJH – Alloy, Metal, Base
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3710
Specialty
Dental

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K040180Continum VEJH · Traditional Aalba Dent, Inc.03/04/2004SE
K040179ContinumEJH · Traditional Aalba Dent, Inc.03/03/2004SE
K033356Verasoft EsEJH · Traditional Aalba Dent, Inc.12/30/2003SE
K033045Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional American Green Dent. Mfg, Inc.12/23/2003SE
K032136Wirobond CEJH · Traditional Bego U.S.A.09/04/2003SE
K031627Nano-TicrownEJH · Traditional Nano-Write Corp.06/11/2003SE
K030632PD Casta-HEJH · Traditional Mountain Medico, Inc.05/07/2003SE
K030416Ceracast-VEJH · Traditional Mountain Medico, Inc.04/14/2003SE
K030161SuperbondEJH · Traditional American Dent-All, Inc.03/17/2003SE

More from American Dent-All, Inc.

510(k)DeviceDecision
K021971CeraloyEJH · Traditional 08/01/2002SE
K021969ChroloyEJH · Traditional 07/30/2002SE
K021968Ceraloy SolderEJH · Traditional 07/26/2002SE
K021965Chroloy SolderEJH · Traditional 07/26/2002SE

Questions and answers

When was Bioloy cleared by the FDA?

Bioloy (K023477) received a 510(k) decision of Substantially Equivalent on December 13, 2002, 58 days after the submission was received.

What is the product code of K023477?

The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.