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FDA 510(k)

PREFORMED DENTAL IMPRESSION TRAYS

K-Number: K850776 · 1985-03-18

ApplicantL.A.K. Ent., Inc.
Decision Date1985-03-18
Product CodeEHY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREFORMED DENTAL IMPRESSION TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is L.A.K. Ent., Inc.. It received FDA 510(k) clearance on 1985-03-18 under 510(k) number K850776. The device is classified under product code EHY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFORMED DENTAL IMPRESSION TRAYS?

PREFORMED DENTAL IMPRESSION TRAYS is a medical device that received FDA 510(k) clearance on 1985-03-18. The listed applicant is L.A.K. Ent., Inc.. The 510(k) number is K850776.

When did PREFORMED DENTAL IMPRESSION TRAYS receive FDA 510(k) clearance?

PREFORMED DENTAL IMPRESSION TRAYS received FDA 510(k) clearance on 1985-03-18, under 510(k) number K850776.

Who is the listed applicant for PREFORMED DENTAL IMPRESSION TRAYS?

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

What is the FDA product code for PREFORMED DENTAL IMPRESSION TRAYS?

The FDA product code for PREFORMED DENTAL IMPRESSION TRAYS is EHY.

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Other records listing L.A.K. Ent., Inc. as applicant

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K850775DENTAL MASSAGING PICKS

Related Devices (Code: EHY)

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Official Source

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

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