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FDA 510(k)

PALATRAY LC RESIN IMPRESSION TRAY MATERIAL

K-Number: K902350 · 1990-07-26

ApplicantKulzer, Inc.
Decision Date1990-07-26
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALATRAY LC RESIN IMPRESSION TRAY MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1990-07-26 under 510(k) number K902350. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALATRAY LC RESIN IMPRESSION TRAY MATERIAL?

PALATRAY LC RESIN IMPRESSION TRAY MATERIAL is a medical device that received FDA 510(k) clearance on 1990-07-26. The listed applicant is Kulzer, Inc.. The 510(k) number is K902350.

When did PALATRAY LC RESIN IMPRESSION TRAY MATERIAL receive FDA 510(k) clearance?

PALATRAY LC RESIN IMPRESSION TRAY MATERIAL received FDA 510(k) clearance on 1990-07-26, under 510(k) number K902350.

Who is the listed applicant for PALATRAY LC RESIN IMPRESSION TRAY MATERIAL?

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

What is the FDA product code for PALATRAY LC RESIN IMPRESSION TRAY MATERIAL?

The FDA product code for PALATRAY LC RESIN IMPRESSION TRAY MATERIAL is EBH.

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Other records listing Kulzer, 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.

K904928PALAVIT GLCK905058PALAVIT LK910263CHARISMAK910719SILICOATER MDK905131DURAFILL COLOR VSK905302DENTHESIVE

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Related Devices (Code: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K923549PALADISC LCHeraeus Kulzer, Inc.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, 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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