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

Material, Impression Tray, Resin

21 CFR 872.3670 / Dental
FDA source (opens on fda.gov)

EBH is the FDA product code for Material, Impression Tray, Resin, a class I device type, regulated under 21 CFR 872.3670. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EBH
Device name
Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
30
Ingested recalls
0

Clearances, product code EBH

By decision year
30 clearances under product code EBH with a decision year between 1976 and 1994, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EBH by decision year
YearClearances
19761
19792
19802
19811
19823
19831
19855
19861
19871
19884
19891
19902
19912
19922
19931
19941

Applicants with the most clearances

Product code EBH
Applicants holding the most 510(k) clearances under product code EBH
ApplicantClearances
Dentsply Intl.5
Kulzer GmbH4
Espe GmbH (US)3
Dentron, Inc.2
3M Company1
Advantage Dental Products, Inc.1
Bio-Systems Research1
Chayet and Sonnenrich, P.C.1
Cutter Laboratories, Inc.1
E&D Dental Manufacturing Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 186 companies shown, in name order