Crack Detector, Den-Mat

FDA 510(k) K770492 · Dey-Mat, Inc.

Substantially Equivalent

510(k) numberK770492

Submission

Device name
Crack Detector, Den-Mat
Applicant
Dey-Mat, Inc.
Mchenry, IL, US
Received
March 14, 1977
Decision date
March 21, 1977
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
K832647Articulating PaperEFH · Traditional Ardent Intl., Inc.02/21/1984SE
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

Questions and answers

When was Crack Detector, Den-Mat cleared by the FDA?

Crack Detector, Den-Mat (K770492) received a 510(k) decision of Substantially Equivalent on March 21, 1977, 7 days after the submission was received.

What is the product code of K770492?

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