Articulating Paper

FDA 510(k) K832647 · Ardent Intl., Inc.

Substantially Equivalent

510(k) numberK832647

Submission

Device name
Articulating Paper
Applicant
Ardent Intl., Inc.
Mchenry, IL, US
Received
August 5, 1983
Decision date
February 21, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EFH – Paper, Articulation
Device class
Class I (low risk)
Regulation
21 CFR 872.6140
Specialty
Dental

Other 510(k)s with product code EFH

510(k)DeviceApplicantDecision
K965026Pfingst Pressure PasteEFH · Traditional Pfingst & Co., Inc.02/10/1997SE
K912632OccludeEFH · Traditional Pascal Co., Inc.01/17/1992SE
K911259HydentEFH · Traditional Pascal Co., Inc.06/06/1991SE
K864572FixtectorEFH · Traditional Prodent Intl., Inc.02/12/1987SE
K870032Revised T-Scan SystemEFH · Traditional Sentek, Inc.02/02/1987SE
K833132Mucosal Adjustment Paste Liquid SprayEFH · Traditional Myo-Tronics Research, Inc.02/10/1984SE
K810498Centric (Bite) Registration PasteEFH · Traditional Wallace A. Erickson & Co.03/17/1981SE
K771011Articulating PaperEFH · Traditional Parker Laboratories, Inc.06/20/1977SE
K770492Crack Detector, Den-MatEFH · Traditional Dey-Mat, Inc.03/21/1977SE

More from Dey-Mat, Inc.

510(k)DeviceDecision
K864300Siliva Ejector/Oral Cavity EvacuatorDYN · Traditional 11/24/1986SE
K842512Exacta-Film · Traditional 06/27/1984SESP

Questions and answers

When was Articulating Paper cleared by the FDA?

Articulating Paper (K832647) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 200 days after the submission was received.

What is the product code of K832647?

The FDA product code is EFH – Paper, Articulation, a Class I (low risk) device regulated under 21 CFR 872.6140.