Peri Mirror/Saliva Ejector

FDA 510(k) K833429 · Dentec, Inc.

Substantially Equivalent

510(k) numberK833429

Submission

Device name
Peri Mirror/Saliva Ejector
Applicant
Dentec, Inc.
Walker, MI, US
Received
October 5, 1983
Decision date
December 22, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EAX – Mirror, Mouth
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EAX

510(k)DeviceApplicantDecision
K946073Oralvue Dental MirrorEAX · Traditional Hines Group , Ltd.02/16/1995SE
K935906Ranir Plax RXEAX · Traditional Ranir/Dcp Corp.09/02/1994SE
K941574Retro MirrorEAX · Traditional Union Broach, Div. Moyco Industries, Inc.05/18/1994SE
K935687NilEAX · Traditional Dentalsafe Systems Pty., Ltd.02/03/1994SE
K863767Glass Mouth Mirrors, ReusableEAX · Traditional The Medical Group, Inc.10/30/1986SE
K863766Disposable Mouth Mirrors, Single Use OnlyEAX · Traditional The Medical Group, Inc.10/30/1986SE
K833310Fogcutter Dental Mouth MirrorEAX · Traditional Hti, Inc.05/07/1984SE
K841199Fiberglass Mouth MirrorsEAX · Traditional Henry Schein, Inc.04/25/1984SE
K830777Electric Mouth MirrorEAX · Traditional Almore Intl., Inc.04/06/1983SE
K821777Beach Mouth MirrorEAX · Traditional Pacific Dental Corp.07/06/1982SE

More from Pacific Dental Corp.

510(k)DeviceDecision
K894930Dentec 4000ETN · Traditional 03/27/1990SE
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Questions and answers

When was Peri Mirror/Saliva Ejector cleared by the FDA?

Peri Mirror/Saliva Ejector (K833429) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 78 days after the submission was received.

What is the product code of K833429?

The FDA product code is EAX – Mirror, Mouth, a Class I (low risk) device regulated under 21 CFR 872.4565.