Impression Tray, MDDS Custom

FDA 510(k) K782153 · Chayet and Sonnenrich, P.C.

Substantially Equivalent

510(k) numberK782153

Submission

Device name
Impression Tray, MDDS Custom
Applicant
Chayet and Sonnenrich, P.C.
Walker, MI, US
Received
December 26, 1978
Decision date
February 26, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EBH – Material, Impression Tray, Resin
Device class
Class I (low risk)
Regulation
21 CFR 872.3670
Specialty
Dental

Other 510(k)s with product code EBH

510(k)DeviceApplicantDecision
K933745Permagen Universal Bonding ResinEBH · Traditional Bio-Systems Research01/26/1994SE
K930487Palatray LC MintEBH · Traditional Heraeus Kulzer, Inc.06/18/1993SE
K923979LC Tray MaterialEBH · Traditional Dentsply Intl.11/17/1992SE
K923549Paladisc LCEBH · Traditional Heraeus Kulzer, Inc.09/29/1992SE
K912820Polyester Resin Hand Molded TrayEBH · Traditional E&D Dental Products, Inc.08/21/1991SE
K905058Palavit LEBH · Traditional Kulzer, Inc.06/06/1991SE
K902350Palatray LC Resin Impression Tray MaterialEBH · Traditional Kulzer, Inc.07/26/1990SE
K901782Convertray Custom Impression Tray Material SystemEBH · Traditional Productivity Training Corp.06/29/1990SE
K890712Advantage Dental Cust Dent Impress/Baseplate TraysEBH · Traditional Advantage Dental Products, Inc.04/25/1989SE
K881838Modified Permagum AdhesiveEBH · Traditional Espe GmbH (Us)07/27/1988SE

Questions and answers

When was Impression Tray, MDDS Custom cleared by the FDA?

Impression Tray, MDDS Custom (K782153) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 62 days after the submission was received.

What is the product code of K782153?

The FDA product code is EBH – Material, Impression Tray, Resin, a Class I (low risk) device regulated under 21 CFR 872.3670.