Den Temp

FDA 510(k) K821581 · Majestic Drug Co., Inc.

Substantially Equivalent

510(k) numberK821581

Submission

Device name
Den Temp
Applicant
Majestic Drug Co., Inc.
Mchenry, IL, US
Received
May 28, 1982
Decision date
June 14, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EMB – Zinc Oxide Eugenol
Device class
Class I (low risk)
Regulation
21 CFR 872.3275
Specialty
Dental

Other 510(k)s with product code EMB

510(k)DeviceApplicantDecision
K161630Provicol QM PlusEMB · Traditional Voco GmbH09/15/2016SE
K120695Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care KitEMB · Traditional Dentist IN A Box Pty., Ltd.06/12/2012SE
K110759TempocemEMB · Abbreviated Dmg USA, Inc.06/10/2011SE
K073539Provisa CemEMB · Traditional Cavex Holland BV01/31/2008SE
K020158Non-Eugenol Temporary CementEMB · Traditional J. Morita USA, Inc.03/07/2002SE
K941066Dental 911EMB · Traditional L.A.F. Industries, Inc.05/24/1995SE
K861681Dentimedic Dental Emergency KitEMB · Traditional Dentimedic09/23/1986SE
K862745Eugenol UspEMB · Traditional E&D Dental Manufacturing Co.07/31/1986SE
K801779Oxydental Zinc Oxide Eugenol(Zoe)CementEMB · Traditional Oxy Dental Products, Inc.08/07/1980SE
K772315KwikapEMB · Traditional Den-Mat Corp.01/03/1978SE

More from Den-Mat Corp.

510(k)DeviceDecision
K101771Reline-It Model Reline-ItEBP · Traditional 09/20/2010SE
K964773Dentemp One StepEMA · Traditional 02/21/1997SE

Questions and answers

When was Den Temp cleared by the FDA?

Den Temp (K821581) received a 510(k) decision of Substantially Equivalent on June 14, 1982, 17 days after the submission was received.

What is the product code of K821581?

The FDA product code is EMB – Zinc Oxide Eugenol, a Class I (low risk) device regulated under 21 CFR 872.3275.