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

Cephalometer

21 CFR 872.1830 / Dental
FDA source (opens on fda.gov)

EAG is the FDA product code for Cephalometer, a class II device type, regulated under 21 CFR 872.1830. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EAG
Device name
Cephalometer
Regulation
21 CFR 872.1830
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
10
Ingested recalls
0

Clearances, product code EAG

By decision year
10 clearances under product code EAG with a decision year between 1978 and 2003, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EAG by decision year
YearClearances
19781
19811
19842
19871
19911
19921
19941
20021
20031

Applicants with the most clearances

Product code EAG
Applicants holding the most 510(k) clearances under product code EAG
ApplicantClearances
Gendex Corp.2
Dolphin Imaging Systems1
J. Morita Mfg. Corp.1
J. Morita USA, Inc.1
Medrad, Inc.1
Modern Systems, Inc.1
Morningstar Dental Co.1
Siemens Corp.1
Teledyne Water Pik1

Companies listing this code with FDA

Companies whose registered establishments list this code