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

Splint, Endodontic Stabilizing

21 CFR 872.3890 / Dental
FDA source (opens on fda.gov)

ELS is the FDA product code for Splint, Endodontic Stabilizing, a class II device type, regulated under 21 CFR 872.3890. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELS
Device name
Splint, Endodontic Stabilizing
Regulation
21 CFR 872.3890
Device class
Class II
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
6
Ingested recalls
0

Clearances, product code ELS

By decision year
6 clearances under product code ELS with a decision year between 1980 and 1997, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELS by decision year
YearClearances
19801
19811
19841
19941
19961
19971

Applicants with the most clearances

Product code ELS
Applicants holding the most 510(k) clearances under product code ELS
ApplicantClearances
C.B.S. Biotechnics, Inc.1
Colmed, Ltd.1
Dentatus USA Ltd.1
Glasspan, Inc.1
Jeneric/Pentron, Inc.1
Zest Anchors LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code