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
EAZClass I

Light, Operating, Dental

21 CFR 872.4630 / Dental
FDA source (opens on fda.gov)

EAZ is the FDA product code for Light, Operating, Dental, a class I device type, regulated under 21 CFR 872.4630. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EAZ
Device name
Light, Operating, Dental
Regulation
21 CFR 872.4630
Device class
Class I
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
23
Ingested recalls
3

Clearances, product code EAZ

By decision year
23 clearances under product code EAZ with a decision year between 1976 and 2007, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EAZ by decision year
YearClearances
19761
19771
19781
19791
19801
19841
19861
19881
19894
19901
19912
19921
19932
19941
20011
20041
20051
20071

Applicants with the most clearances

Product code EAZ
Applicants holding the most 510(k) clearances under product code EAZ
ApplicantClearances
Addent, Inc.2
Trylon Corp.2
A-dec, Inc.1
Chemetron Dental Products1
Dabi-Atlante America Corp.1
Defiance Electronics, Inc.1
Den-Tal-Ez Mfg Co., Inc.1
Dentsply Intl.1
Eurodent, Inc.1
Innovators, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order