Dentflex Displosable Dental Saliva Ejector

FDA 510(k) K940769 · Terraflex

Substantially Equivalent

510(k) numberK940769

Submission

Device name
Dentflex Displosable Dental Saliva Ejector
Applicant
Terraflex
Efrat 90962, IL
Received
February 18, 1994
Decision date
August 17, 1994
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
K935758Hygoflex Saliva-EjectorDYN · Traditional J.H.Orsing AB03/21/1994SE
K935616Saliva Ejector DisposableDYN · Traditional Asa Instruments S.R.L.03/21/1994SE
K924211EjectorDYN · Traditional Glenroe Technologies03/31/1993SE
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

Questions and answers

When was Dentflex Displosable Dental Saliva Ejector cleared by the FDA?

Dentflex Displosable Dental Saliva Ejector (K940769) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 180 days after the submission was received.

What is the product code of K940769?

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