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

Bur, Dental

21 CFR 872.3240 / Dental
FDA source (opens on fda.gov)

EJL is the FDA product code for Bur, Dental, a class I device type, regulated under 21 CFR 872.3240. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
EJL
Device name
Bur, Dental
Regulation
21 CFR 872.3240
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
27
Ingested recalls
13

Clearances, product code EJL

By decision year
27 clearances under product code EJL with a decision year between 1976 and 2008, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EJL by decision year
YearClearances
19761
19774
19781
19803
19821
19831
19851
19863
19871
19881
19912
19922
19931
19942
20061
20071
20081

Applicants with the most clearances

Product code EJL
Applicants holding the most 510(k) clearances under product code EJL
ApplicantClearances
Almore Intl., Inc.2
Swiss American Metal Craft Corp.2
A & M Instruments, Inc.1
Adp Intl., Inc.1
Aesculap Instruments Corp.1
B.T.I. Biotechnology Institute, S.L.1
Beavers Dental, Div. Sybron Canada, Ltd.1
Brevet Inc.1
Cutter Laboratories, Inc.1
Den-Mat Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 260 companies shown, in name order