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FDA 510(k)

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

K-Number: K053065 · 2006-01-03

ApplicantBryan Keropian Dds
Decision Date2006-01-03
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) is the device name listed in this FDA 510(k) record. The listed applicant is Bryan Keropian Dds. It received FDA 510(k) clearance on 2006-01-03 under 510(k) number K053065. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)?

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) is a medical device that received FDA 510(k) clearance on 2006-01-03. The listed applicant is Bryan Keropian Dds. The 510(k) number is K053065.

When did FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) receive FDA 510(k) clearance?

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) received FDA 510(k) clearance on 2006-01-03, under 510(k) number K053065.

Who is the listed applicant for FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)?

The FDA 510(k) record lists Bryan Keropian Dds as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)?

The FDA product code for FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) is LQZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bryan Keropian Dds 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.

K091035FULL BREATH SLEEP APPLIANCE LOWER (FBSL)K061228FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSORK052862FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)

Related Devices (Code: LQZ)

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.

K233754AIO BreatheAiomega, LLCK230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLCK203712The SlideBiotex, Inc.K191320Slow Wave DS8Slow Wave, Inc.K192581The NightBlocks ApplianceAdvanced Facialdontics, LLCK162816SML-OSA2 AppliancesSelane Products, Inc.

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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