DEFEND Ear-loop Face Masks
FDA 510(k) K201127 · Young Dental Manufacturing Co. 1, LLC
510(k) numberK201127
Submission
- Device name
- DEFEND Ear-loop Face Masks
- Applicant
- Young Dental Manufacturing Co. 1, LLC
Earth City, MO, US - Received
- April 28, 2020
- Decision date
- April 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FXX – Mask, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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| K252534 | Surgical Face Mask (Ear mount)FXX · Traditional | Zhejiang Hangkang Medical Equipment Co., Ltd. | 03/03/2026SE |
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| K252830 | Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional | Beatles Medical Supplies (Xiantao) Co., Ltd. | 01/12/2026SE |
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| K243342 | KP Protective Face MaskFXX · Traditional | Kp Trading Co., Ltd. | 12/22/2025SE |
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| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 11/04/2025SE |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional | Vitacore Industries, Inc. | 09/17/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 06/18/2025SE |
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| K153334 | Oral-B 5% Sodium Fluoride VarnishLBH · Traditional | 05/20/2016SE |
| K932255 | Young D'GranulatorKMW · Traditional | 04/15/1994SE |
| K903284 | Young Prophy System, PS UnitKOJ · Traditional | 12/17/1990SE |
| K875340 | Jetpolisher(Tm)KOJ · Traditional | 06/10/1988SE |
| K875339 | Jetpolisher Airpolishing PowderEJR · Traditional | 04/18/1988SE |
| K821484 | Dawn Low Speed Handpiece SystemEFB · Traditional | 06/09/1982SE |
| K790723 | Prophylaxis Cups and PolishersEHK · Traditional | 06/15/1979SE |
| K790722 | Prophylaxis AngleEGS · Traditional | 06/15/1979SE |
Questions and answers
When was DEFEND Ear-loop Face Masks cleared by the FDA?
DEFEND Ear-loop Face Masks (K201127) received a 510(k) decision of Substantially Equivalent on April 14, 2021, 351 days after the submission was received.
What is the product code of K201127?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.