Home › Device types › EFN
Cotton, Roll
FDA product code EFN · Class 1 · Dental
134
Registered devices
7
Adverse events
2
Recalls
14
510(k) clearances
Devices with this code
MEDICOM SAFEBASICS — AMD Medicom IncSupplies — AMERICAN ORTHODONTICS CORPORATIONSupplies — AMERICAN ORTHODONTICS CORPORATIONSupplies — AMERICAN ORTHODONTICS CORPORATIONJMU — JMU DENTAL, INCJMU — JMU DENTAL, INCRospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLCDeRoyal — DEROYAL INDUSTRIES, INC.Crosstex International — CROSSTEX INTERNATIONAL, INC.Cylindrical Sponge — AMERICAN SURGICAL COMPANY, LLCIsolator Disposable Cotton Roll Holder 50 Pack — PASCAL COMPANY, INC.NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc.SAFE DENT — BGSS Company Inc.Henry Schein — HENRY SCHEIN, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Henry Schein — HENRY SCHEIN, INC.Henry Schein — HENRY SCHEIN, INC.iSmile — Ismile Dental Products, Inc.Supplies — AMERICAN ORTHODONTICS CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Cotton Rolls, Non-Sterile, Advantage Plus — CROSSTEX INTERNATIONAL, INC.Supplies — AMERICAN ORTHODONTICS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-02 | Carwild Corporation | Sterility with new cotton source not validated |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
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