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FDA 510(k)

CUSTOM COMFORT NIGHTGUARD

K-Number: K083400 · 2008-12-11

ApplicantDen Tek Oral Care, Inc.
Decision Date2008-12-11
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

CUSTOM COMFORT NIGHTGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Den Tek Oral Care, Inc.. It received FDA 510(k) clearance on 2008-12-11 under 510(k) number K083400. 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 CUSTOM COMFORT NIGHTGUARD?

CUSTOM COMFORT NIGHTGUARD is a medical device that received FDA 510(k) clearance on 2008-12-11. The listed applicant is Den Tek Oral Care, Inc.. The 510(k) number is K083400.

When did CUSTOM COMFORT NIGHTGUARD receive FDA 510(k) clearance?

CUSTOM COMFORT NIGHTGUARD received FDA 510(k) clearance on 2008-12-11, under 510(k) number K083400.

Who is the listed applicant for CUSTOM COMFORT NIGHTGUARD?

The FDA 510(k) record lists Den Tek Oral Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM COMFORT NIGHTGUARD?

The FDA product code for CUSTOM COMFORT NIGHTGUARD is OBR. This falls under the Orthopedic category.

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Other records listing Den Tek Oral Care, 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.

K130186DENTEK EASY BRUSH WITH FLUORIDEK123849NEW COMFORT-FIT DENTAL GUARDK091660CUSTOM COMFORT NIGHTGUARD VERSION 2K081669IMPROVED COMFORT-FIT NIGHTGUARDK072147DEN TEK COMFORT FIT NIGHTGUARDK063483DEN TEK NIGHTGUARD

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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.

K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd.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 GuardRemi

Official Source

View on FDA Database →

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

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