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

Coating, Denture Hydrophilic, Resin

21 CFR 872.3300 / Dental
FDA source (opens on fda.gov)

EBE is the FDA product code for Coating, Denture Hydrophilic, Resin, a class II device type, regulated under 21 CFR 872.3300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EBE
Device name
Coating, Denture Hydrophilic, Resin
Regulation
21 CFR 872.3300
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
3
Ingested recalls
0

Clearances, product code EBE

By decision year
3 clearances under product code EBE with a decision year between 1979 and 1983, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EBE by decision year
YearClearances
19791
19832

Applicants with the most clearances

Product code EBE
Applicants holding the most 510(k) clearances under product code EBE
ApplicantClearances
Chema-Scutum, Inc.1
Johnson & Johnson Professionals, Inc.1
Richardson Merrel, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code