Home › Device types › EFN
Cotton, Roll
FDA product code EFN · Class 1 · Dental
134
Registered devices
10
Adverse events
2
Recalls
14
510(k) clearances
Devices with this code
Isolator Disposable Cotton Roll Holder 50 Pack — PASCAL COMPANY, INC.Henry Schein — HENRY SCHEIN, INC.SURGYCO — Surgyco LLCHenry Schein — HENRY SCHEIN, INC.Defend — Young Innovations, Inc.Cylindrical Sponge — AMERICAN SURGICAL COMPANY, LLCJMU — JMU DENTAL, INCDeRoyal — DEROYAL INDUSTRIES, INC.MARK3 — CARGUS INTERNATIONAL, INCDefend — YOUNG MYDENT, LLCDeRoyal — DEROYAL INDUSTRIES, INC.Aira — AIRA, LLCATOMO — ATOMO DENTAL, INC.Parkell® — PARKELL, INC.Cylindrical Sponge — AMERICAN SURGICAL COMPANY, LLCAvaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanySAFE DENT — BGSS Company Inc.Crosstex International — CROSSTEX INTERNATIONAL, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyDeRoyal — DEROYAL INDUSTRIES, INC.Supplies — AMERICAN ORTHODONTICS CORPORATIONSupplies — AMERICAN ORTHODONTICS CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLC
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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