Product code EHL— Dental

CUTTER POINTS

Classification name: Point, Abrasive
Device class: Class 1
Regulation: 21 CFR 872.6010
Advisory panel: Dental
Total cleared: 4
First cleared: 1978-03-14
Most recent: 1980-01-23

Market context for product code EHL

FDA has cleared 4 devices under product code EHL between 1978 and 1980, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19801 clearance
19783 clearances

Top applicants under product code EHL

Cavitron Corp.3 clearances
Cutter Laboratories, Inc.1 clearance

Recent clearances under product code EHL

K792250 — CUTTER POINTSCutter Laboratories, Inc.·1980-01-23
K780811 — DENTAL ABRASIVE DEVICECavitron Corp.·1978-06-22
K780376 — MINIDENTOFLEX NEW POLISHING SYSTEMCavitron Corp.·1978-03-14
K780377 — PINIDENTOFLEX DENTAL POLISHERCavitron Corp.·1978-03-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.