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

Wax, Dental, Intraoral

21 CFR 872.6890 / Dental
FDA source (opens on fda.gov)

EGD is the FDA product code for Wax, Dental, Intraoral, a class I device type, regulated under 21 CFR 872.6890. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EGD
Device name
Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
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
25
Ingested recalls
0

Clearances, product code EGD

By decision year
25 clearances under product code EGD with a decision year between 1980 and 2002, 1989 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code EGD by decision year
YearClearances
19801
19822
19851
19864
19882
19896
19912
19925
19951
20021

Applicants with the most clearances

Product code EGD
Applicants holding the most 510(k) clearances under product code EGD
ApplicantClearances
Pemaco, Inc.7
Columbus Dental Mfg. Co.3
Kulzer GmbH3
The Hygenic Company, LLC3
Dentsply Intl.2
Modern Materials2
Glenroe Technologies1
Howmedica Corp.1
Orion Diagnostica, Inc.1
Toothprints, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order