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

Unit, Oral Irrigation

21 CFR 872.6510 / Dental
FDA source (opens on fda.gov)

EFS is the FDA product code for Unit, Oral Irrigation, a class I device type, regulated under 21 CFR 872.6510. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EFS
Device name
Unit, Oral Irrigation
Regulation
21 CFR 872.6510
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
47
Ingested recalls
0

Clearances, product code EFS

By decision year
47 clearances under product code EFS with a decision year between 1980 and 2002, 1990 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code EFS by decision year
YearClearances
19802
19812
19822
19833
19843
19852
19861
19871
19884
19894
19906
19915
19923
19931
19943
19951
19971
19981
20001
20021

Applicants with the most clearances

Product code EFS
Applicants holding the most 510(k) clearances under product code EFS
ApplicantClearances
Teledyne Water Pik5
Teledyne, Inc.4
Dentsply Intl.3
Vipont Laboratories, Inc.3
Micro Motors, Inc.2
Air Force, Inc.1
Bausch & Lomb Incorporated1
Colgate-Palmolive Company1
Collagen Corp.1
Core-Vent Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 216 companies shown, in name order