Occlusal Harmony Impression Tray

FDA 510(k) K884316 · Advantage Dental Co.

Substantially Equivalent

510(k) numberK884316

Submission

Device name
Occlusal Harmony Impression Tray
Applicant
Advantage Dental Co.
Auburn Hills, MI, US
Received
October 13, 1988
Decision date
December 22, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EHY – Tray, Impression, Preformed
Device class
Class I (low risk)
Regulation
21 CFR 872.6880
Specialty
Dental

Other 510(k)s with product code EHY

510(k)DeviceApplicantDecision
K942668O-Tray Impression TraysEHY · Traditional Dentauraum, Inc.07/22/1994SE
K896470Eos Impression TraysEHY · Traditional Ivoclar North America, Inc.02/09/1990SE
K863836Post TrayEHY · Traditional Market Masters, Inc.10/14/1986SE
K850776Preformed Dental Impression TraysEHY · Traditional L.A.K. Ent., Inc.03/18/1985SE
K842274F-G-P TrayEHY · Traditional Di-Equi Dental Products07/31/1984SE
K842273Crown Index TrayEHY · Traditional Di-Equi Dental Products07/31/1984SE
K841491Conventional Plastic Dental TraysEHY · Traditional Buffalo Dental Mfg. Co., Inc.07/13/1984SE
K841323Fuzzy TrayEHY · Traditional Buffalo Dental Mfg. Co., Inc.06/27/1984SE
K833485Impression Tube AdjustableEHY · Traditional Zefr, Inc.12/26/1983SE
K810525Sr-Ivotray UniversalEHY · Traditional J. Aderer, Inc.03/17/1981SE

Questions and answers

When was Occlusal Harmony Impression Tray cleared by the FDA?

Occlusal Harmony Impression Tray (K884316) received a 510(k) decision of Substantially Equivalent on December 22, 1988, 70 days after the submission was received.

What is the product code of K884316?

The FDA product code is EHY – Tray, Impression, Preformed, a Class I (low risk) device regulated under 21 CFR 872.6880.