Uls 8-86

FDA 510(k) K863163 · American Instrument Manufacturer'S, Inc.

Substantially Equivalent

510(k) numberK863163

Submission

Device name
Uls 8-86
Applicant
American Instrument Manufacturer'S, Inc.
Eureka, MO, US
Received
August 18, 1986
Decision date
September 22, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
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

More from Ardent Intl., Inc.

510(k)DeviceDecision
K880669L-5 Plastic Surgery CannulasGEA · Traditional 03/17/1988SE

Questions and answers

When was Uls 8-86 cleared by the FDA?

Uls 8-86 (K863163) received a 510(k) decision of Substantially Equivalent on September 22, 1986, 35 days after the submission was received.

What is the product code of K863163?

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