Device Atlas

Revised T-Scan System

Q: What is the product code of K870032?

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

FDA 510(k) K870032 · Sentek, Inc.

Substantially Equivalent

510(k) numberK870032

Submission

Device name: Revised T-Scan System
Applicant: Sentek, Inc.
Washington, DC, US
Received: January 5, 1987
Decision date: February 2, 1987
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)	Device	Applicant	Decision
K965026	Pfingst Pressure PasteEFH · Traditional	Pfingst & Co., Inc.	02/10/1997SE
K912632	OccludeEFH · Traditional	Pascal Co., Inc.	01/17/1992SE
K911259	HydentEFH · Traditional	Pascal Co., Inc.	06/06/1991SE
K864572	FixtectorEFH · Traditional	Prodent Intl., Inc.	02/12/1987SE
K832647	Articulating PaperEFH · Traditional	Ardent Intl., Inc.	02/21/1984SE
K833132	Mucosal Adjustment Paste Liquid SprayEFH · Traditional	Myo-Tronics Research, Inc.	02/10/1984SE
K810498	Centric (Bite) Registration PasteEFH · Traditional	Wallace A. Erickson & Co.	03/17/1981SE
K771011	Articulating PaperEFH · Traditional	Parker Laboratories, Inc.	06/20/1977SE
K770492	Crack Detector, Den-MatEFH · Traditional	Dey-Mat, Inc.	03/21/1977SE

Questions and answers

When was Revised T-Scan System cleared by the FDA?

Revised T-Scan System (K870032) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 28 days after the submission was received.

What is the product code of K870032?

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