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

Instrument, Hand, Calculus Removal

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

ELA is the FDA product code for Instrument, Hand, Calculus Removal, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELA
Device name
Instrument, Hand, Calculus Removal
Regulation
21 CFR 872.4565
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
4
Ingested recalls
0

Clearances, product code ELA

By decision year
4 clearances under product code ELA with a decision year between 1980 and 1995, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELA by decision year
YearClearances
19801
19821
19861
19951

Applicants with the most clearances

Product code ELA
Applicants holding the most 510(k) clearances under product code ELA
ApplicantClearances
Analytic Technology1
Ela Medical, Inc.1
Miltex, Inc.1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order