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

Mirror, Mouth

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

EAX is the FDA product code for Mirror, Mouth, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EAX
Device name
Mirror, Mouth
Regulation
21 CFR 872.4565
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
12
Ingested recalls
1

Clearances, product code EAX

By decision year
12 clearances under product code EAX with a decision year between 1980 and 1995, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EAX by decision year
YearClearances
19801
19821
19832
19842
19862
19943
19951

Applicants with the most clearances

Product code EAX
Applicants holding the most 510(k) clearances under product code EAX
ApplicantClearances
Medical Group2
Almore Intl., Inc.1
Dentalsafe Systems Pty., Ltd.1
Dentec, Inc.1
Henry Schein, Inc.1
Hines Group, Ltd.1
Hti, Inc.1
Pacific Dental Corp.1
Ranir/Dcp Corp.1
Teledyne, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 367 companies shown, in name order