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

Light, Surgical Headlight

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

EBA is the FDA product code for Light, Surgical Headlight, a class I device type, regulated under 21 CFR 872.4630. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
EBA
Device name
Light, Surgical Headlight
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
10
Ingested recalls
5

Clearances, product code EBA

By decision year
10 clearances under product code EBA with a decision year between 1979 and 2007, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EBA by decision year
YearClearances
19792
19811
19821
19842
19861
19891
19921
20071

Applicants with the most clearances

Product code EBA
Applicants holding the most 510(k) clearances under product code EBA
ApplicantClearances
Harry J. Bosworth Co.2
Alpine Dental Equipment Co.1
Colmed, Ltd.1
Cuda Products Co.1
Good-Lite Co.1
Kelleher Corp.1
Photonic Optische Gerate GmbH & Cokg1
Planmeca U.S.A. Inc1
Sylvan Medical Fiberoptics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order