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

Unit, Suction Operatory

21 CFR 872.6640 / Dental
FDA source (opens on fda.gov)

EBR is the FDA product code for Unit, Suction Operatory, a class I device type, regulated under 21 CFR 872.6640. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EBR
Device name
Unit, Suction Operatory
Regulation
21 CFR 872.6640
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
3
Ingested recalls
3

Clearances, product code EBR

By decision year
3 clearances under product code EBR with a decision year between 1977 and 1994, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EBR by decision year
YearClearances
19771
19861
19941

Applicants with the most clearances

Product code EBR
Applicants holding the most 510(k) clearances under product code EBR
ApplicantClearances
A-dec, Inc.1
Nissho Iwai American Corp.1
W.H. Wall, D.D.S.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order