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

Cotton, Roll

21 CFR 872.6050 / Dental
FDA source (opens on fda.gov)

EFN is the FDA product code for Cotton, Roll, a class I device type, regulated under 21 CFR 872.6050. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
EFN
Device name
Cotton, Roll
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
14
Ingested recalls
2

Clearances, product code EFN

By decision year
14 clearances under product code EFN with a decision year between 1977 and 1987, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EFN by decision year
YearClearances
19771
19791
19801
19812
19831
19842
19851
19863
19872

Applicants with the most clearances

Product code EFN
Applicants holding the most 510(k) clearances under product code EFN
ApplicantClearances
Intl. Verbandstoff-Fabrik Schaffhau2
American Silk Sutures, Inc.1
Cross Country Paper Products Corp.1
Henry Schein, Inc.1
Hoyt Laboratories1
Lorvic Corp.1
Medgroup Enterprises, Inc.1
Medspec Corp.1
Molnlycke A/S Hospital Products1
Parker Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order