Ejector

FDA 510(k) K924211 · Glenroe Technologies

Substantially Equivalent

510(k) numberK924211

Submission

Device name
Ejector
Applicant
Glenroe Technologies
Bradenton, FL, US
Received
August 20, 1992
Decision date
March 31, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DYN – Mouthpiece, Saliva Ejector
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Specialty
Dental

Other 510(k)s with product code DYN

510(k)DeviceApplicantDecision
K940769Dentflex Displosable Dental Saliva EjectorDYN · Traditional Terraflex08/17/1994SE
K935758Hygoflex Saliva-EjectorDYN · Traditional J.H.Orsing AB03/21/1994SE
K935616Saliva Ejector DisposableDYN · Traditional Asa Instruments S.R.L.03/21/1994SE
K920492High VacDYN · Traditional Hygoplastic, Inc.05/11/1992SE
K921117MinidamDYN · Traditional Delsan Dental Systems05/05/1992SE
K900631Saliva Absorber - DentalDYN · Traditional Kab Gloves Unltd.04/04/1990SE
K871315Oral AspiratorDYN · Traditional Endovations04/15/1987SE
K870599Tip, Dental Suction ApparatusDYN · Traditional Military Engineering, Inc.03/23/1987SE
K864300Siliva Ejector/Oral Cavity EvacuatorDYN · Traditional Ardent Intl., Inc.11/24/1986SE
K863768Saliva EjectorsDYN · Traditional The Medical Group, Inc.10/27/1986SE

More from The Medical Group, Inc.

510(k)DeviceDecision
K980053Glenroe ChainECI · Traditional 02/24/1998SE
K945535Glenroe Ortho-SilEGD · Traditional 01/27/1995SE
K924351Glenroe Elastibite StimulatorKMY · Traditional 01/06/1994SE
K932920Glenroe Plastic BracketDYW · Traditional 08/24/1993SE
K931462Glenroe ChainECI · Traditional 07/22/1993SE
K924140Tuff TiesECI · Traditional 04/27/1993SE
K924139Glenroe Ortho SepsECI · Traditional 04/08/1993SE
K924993Glenroe Band Seating Contouring InstrumentECS · Traditional 11/25/1992SE

Questions and answers

When was Ejector cleared by the FDA?

Ejector (K924211) received a 510(k) decision of Substantially Equivalent on March 31, 1993, 223 days after the submission was received.

What is the product code of K924211?

The FDA product code is DYN – Mouthpiece, Saliva Ejector, a Class I (low risk) device regulated under 21 CFR 872.6640.