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

Activator, Ultraviolet, For Polymerization

21 CFR 872.6070 / Dental
FDA source (opens on fda.gov)

EBZ is the FDA product code for Activator, Ultraviolet, For Polymerization, a class II device type, regulated under 21 CFR 872.6070. As of , FDA records hold 214 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
EBZ
Device name
Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
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
214
Ingested recalls
4

Clearances, product code EBZ

By decision year
214 clearances under product code EBZ with a decision year between 1977 and 2026, 2002 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code EBZ by decision year
YearClearances
19775
19783
19801
19812
19823
19831
19843
19851
19861
19882
19893
19903
19914
19921
19931
19943
19956
19967
19974
19982
19998
20009
20019
200215
200313
200412
200510
20069
200710
20085
20094
20101
20113
20121
20133
20143
20154
20164
20178
20182
20195
20205
20211
20225
20233
20241
20254
20261

Applicants with the most clearances

Product code EBZ
Applicants holding the most 510(k) clearances under product code EBZ
ApplicantClearances
Sybron Dental Specialties, Inc.9
Monitex Industrial Co., Ltd.9
Ivoclar Vivadent, Inc.8
Rolence Enterprise Co., Ltd.8
Ultradent Products Inc.7
Dentsply Intl.5
Kulzer GmbH5
Apoza Enterprise Co., Ltd.4
Dentmate Technology Co., Ltd.4
Good Doctors Co., Ltd.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 101 companies shown, in name order