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FDA 510(k)

ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD

K-Number: K113326 · 2012-06-27

ApplicantOralabs, Inc.
Decision Date2012-06-27
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Oralabs, Inc.. It received FDA 510(k) clearance on 2012-06-27 under 510(k) number K113326. 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 ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD?

ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD is a medical device that received FDA 510(k) clearance on 2012-06-27. The listed applicant is Oralabs, Inc.. The 510(k) number is K113326.

When did ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD receive FDA 510(k) clearance?

ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD received FDA 510(k) clearance on 2012-06-27, under 510(k) number K113326.

Who is the listed applicant for ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD?

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

What is the FDA product code for ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD?

The FDA product code for ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD is OBR. This falls under the Orthopedic category.

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Other records listing Oralabs, 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.

K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray

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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