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

Teeth, Porcelain

21 CFR 872.3920 / Dental
FDA source (opens on fda.gov)

ELL is the FDA product code for Teeth, Porcelain, a class II device type, regulated under 21 CFR 872.3920. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELL
Device name
Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
39
Ingested recalls
0

Clearances, product code ELL

By decision year
39 clearances under product code ELL with a decision year between 1977 and 2024, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code ELL by decision year
YearClearances
19771
19781
19801
19821
19842
19852
19861
19872
19884
19892
19902
19912
19922
19934
19941
19962
19971
20042
20061
20071
20162
20221
20241

Applicants with the most clearances

Product code ELL
Applicants holding the most 510(k) clearances under product code ELL
ApplicantClearances
Dentsply Intl.5
Nobel Biocare AB5
Den-Mat Corp.2
G-C Intl. Corp.2
Ivoclar North America, Inc.2
Jeneric/Pentron, Inc.2
Shofu Dental Corp.2
Unicep2
American Thermocraft Corp.1
Argen Precious Metals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order