510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EBDClass II

Coating, Filling Material, Resin

21 CFR 872.3310 / Dental
FDA source (opens on fda.gov)

EBD is the FDA product code for Coating, Filling Material, Resin, a class II device type, regulated under 21 CFR 872.3310. As of , FDA records hold 52 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EBD
Device name
Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
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
52
Ingested recalls
0

Clearances, product code EBD

By decision year
52 clearances under product code EBD with a decision year between 1976 and 2026, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EBD by decision year
YearClearances
19761
19781
19793
19811
19824
19831
19841
19855
19862
19901
19911
19941
19982
19992
20011
20022
20034
20041
20053
20061
20071
20083
20091
20131
20141
20171
20181
20211
20231
20241
20251
20261

Applicants with the most clearances

Product code EBD
Applicants holding the most 510(k) clearances under product code EBD
ApplicantClearances
Bisco Inc6
Scientific Pharmaceuticals, Inc.4
Cosmedent, Inc.3
3M Company2
Dentsply Intl.2
GC America Inc.2
Kerr Dental Materials Center2
Parkell, Inc.2
3M Company1
Austenal Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order