Plastic Mounting Rings

FDA 510(k) K854702 · Almore Intl., Inc.

Substantially Equivalent

510(k) numberK854702

Submission

Device name
Plastic Mounting Rings
Applicant
Almore Intl., Inc.
Portland, OR, US
Received
November 21, 1985
Decision date
March 6, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJP – Articulators
Device class
Class I (low risk)
Regulation
21 CFR 872.3150
Specialty
Dental

Other 510(k)s with product code EJP

510(k)DeviceApplicantDecision
K926190Alrand Inc. (Dental Hand Instruments)EJP · Traditional Alrand, Inc.01/18/1994SE
K896131Gnathomat ArticulatorEJP · Traditional Ivoclar North America, Inc.12/04/1989SE
K892373Dental Plastic Bite ForkEJP · Traditional Texapol Corp.06/12/1989SE
K884418Premier Die-Trak ArticulatorEJP · Traditional Premier Medical11/14/1988SE
K872943Disposable ArticulatorEJP · Traditional Dentsply Intl.08/11/1987SE
K863009Gnatus Articulator 4.300/4.300GP 8.600 & OrtoflexEJP · Traditional Sds Dental, Inc.09/25/1986SE
K833039Handy IimEJP · Traditional Shofu Dental Corp.10/04/1983SE
K811075Balance ArticulatorEJP · Traditional Almore Intl., Inc.05/13/1981SE
K810971The GnatometEJP · Traditional Bauer, Cheng & Associates, Inc.05/05/1981SE
K801342Disposable ArticulatorEJP · Traditional Williams Gold Refining Co., Inc.07/08/1980SE

More from Williams Gold Refining Co., Inc.

510(k)DeviceDecision
K862851Almore Face Mask · Traditional 08/12/1986SE
K854692Monarch II Bleaching InstrumentEEG · Traditional 05/12/1986SE
K854696Op II Visible Light Curing SystemEBZ · Traditional 03/26/1986SE
K854691Diamond Burs-HandpieceEJL · Traditional 03/25/1986SE
K854690Diamonds Burs-Composit FinishingEJL · Traditional 03/25/1986SE
K854700Ez-On Tubing Conditioner (Lubricant) · Traditional 03/12/1986SE
K854701Retract-A-CordJES · Traditional 03/06/1986SE
K854697Tubing Handpiece ReplacementEFB · Traditional 03/06/1986SE
K854699Tubing SyringECB · Traditional 01/06/1986SE
K831136Double Bow Tooth SeparatorJEP · Traditional 06/08/1983SE

Questions and answers

When was Plastic Mounting Rings cleared by the FDA?

Plastic Mounting Rings (K854702) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 105 days after the submission was received.

What is the product code of K854702?

The FDA product code is EJP – Articulators, a Class I (low risk) device regulated under 21 CFR 872.3150.