Advantage Dental Cust Dent Impress/Baseplate Trays

FDA 510(k) K890712 · Advantage Dental Products, Inc.

Substantially Equivalent

510(k) numberK890712

Submission

Device name
Advantage Dental Cust Dent Impress/Baseplate Trays
Applicant
Advantage Dental Products, Inc.
Auburn Hills, MI, US
Received
February 13, 1989
Decision date
April 25, 1989
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

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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
K881838Modified Permagum AdhesiveEBH · Traditional Espe GmbH (Us)07/27/1988SE
K875257Impregum F AdhesiveEBH · Traditional Espe GmbH (Us)03/09/1988SE

More from Espe GmbH (Us)

510(k)DeviceDecision
K990779Hemaseal & CideLBH · Traditional 11/17/1999SE
K900389Temporary Crown Matrix ButtonsEBG · Traditional 07/13/1990SE

Questions and answers

When was Advantage Dental Cust Dent Impress/Baseplate Trays cleared by the FDA?

Advantage Dental Cust Dent Impress/Baseplate Trays (K890712) received a 510(k) decision of Substantially Equivalent on April 25, 1989, 71 days after the submission was received.

What is the product code of K890712?

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