510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EHLClass I

Point, Abrasive

21 CFR 872.6010 / Dental
FDA source (opens on fda.gov)

EHL is the FDA product code for Point, Abrasive, a class I device type, regulated under 21 CFR 872.6010. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EHL
Device name
Point, Abrasive
Regulation
21 CFR 872.6010
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code EHL

By decision year
4 clearances under product code EHL with a decision year between 1978 and 1980, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EHL by decision year
YearClearances
19783
19801

Applicants with the most clearances

Product code EHL
Applicants holding the most 510(k) clearances under product code EHL
ApplicantClearances
Cavitron Corp.3
Cutter Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 84 companies shown, in name order