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FDA 510(k)

ELASTOMERIC SLEEP APPLIANCE

K-Number: K946112 · 1995-06-14

ApplicantVillage Park Orthodontics
Decision Date1995-06-14
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELASTOMERIC SLEEP APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Village Park Orthodontics. It received FDA 510(k) clearance on 1995-06-14 under 510(k) number K946112. 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 ELASTOMERIC SLEEP APPLIANCE?

ELASTOMERIC SLEEP APPLIANCE is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Village Park Orthodontics. The 510(k) number is K946112.

When did ELASTOMERIC SLEEP APPLIANCE receive FDA 510(k) clearance?

ELASTOMERIC SLEEP APPLIANCE received FDA 510(k) clearance on 1995-06-14, under 510(k) number K946112.

Who is the listed applicant for ELASTOMERIC SLEEP APPLIANCE?

The FDA 510(k) record lists Village Park Orthodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELASTOMERIC SLEEP APPLIANCE?

The FDA product code for ELASTOMERIC SLEEP APPLIANCE is LQZ.

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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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