DenTek Fresh Protect Dental Guard— 510(k) K202974

Name: FDA 510(k) clearance K202974
Creator: U.S. Food and Drug Administration
Published: 2020-12-22

Substantially Equivalent

Medtech Products, Inc.

FDA 510(k) clearance K202974 for DenTek Fresh Protect Dental Guard, Substantially Equivalent on 2020-12-22. Applicant: Medtech Products, Inc.. Device class: Unclassified.

Clearance details

Applicant: Medtech Products, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-09-30
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBR

view all

K260790 — G-Series Grind Guard2026-06-25
K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))2026-04-10
K253641 — Owl Night Guard2026-02-26
K252004 — enCore Night Guard2025-11-25
K251778 — Remi Custom Night Guard2025-10-17

More clearances from Medtech Products, Inc.

view all

K242803 — Compound W Skin Tag Remover2024-11-06
K180933 — DenTek Ultimate Dental Guard2018-09-17
K172373 — Compound W Nitro-Freeze2017-11-02
K163401 — Nix Ultra Lice Treatment Kit2017-03-21
K161294 — Compound W Wart Removal System Dual Power2016-09-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.