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FDA 510(k)

Dentemp Pro-Comfort Dental Guard

K-Number: K250456 · 2025-05-19

ApplicantDoc Brands, Inc.
Decision Date2025-05-19
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Dentemp Pro-Comfort Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Doc Brands, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250456. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentemp Pro-Comfort Dental Guard?

Dentemp Pro-Comfort Dental Guard is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Doc Brands, Inc.. The 510(k) number is K250456.

When did Dentemp Pro-Comfort Dental Guard receive FDA 510(k) clearance?

Dentemp Pro-Comfort Dental Guard received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250456.

Who is the listed applicant for Dentemp Pro-Comfort Dental Guard?

The FDA 510(k) record lists Doc Brands, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentemp Pro-Comfort Dental Guard?

The FDA product code for Dentemp Pro-Comfort Dental Guard is OBR. This falls under the Orthopedic category.

Other records listing Doc Brands, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222424Protect-It Custom Fit Dental Guard

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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