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FDA 510(k)

DENTAL HYGIENE TRAY

K-Number: K944139 · 1994-12-15

ApplicantSterile Concepts, Inc.
Decision Date1994-12-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DENTAL HYGIENE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K944139. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL HYGIENE TRAY?

DENTAL HYGIENE TRAY is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K944139.

When did DENTAL HYGIENE TRAY receive FDA 510(k) clearance?

DENTAL HYGIENE TRAY received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944139.

Who is the listed applicant for DENTAL HYGIENE TRAY?

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

What is the FDA product code for DENTAL HYGIENE TRAY?

The FDA product code for DENTAL HYGIENE TRAY is LYY.

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Other records listing Sterile Concepts, Inc. as applicant

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Related Devices (Code: LYY)

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.

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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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