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FDA 510(k)

RESIN TRAY IMPRESSION MATERIAL

K-Number: K854042 · 1985-11-07

ApplicantDentsply Intl.
Decision Date1985-11-07
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESIN TRAY IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-11-07 under 510(k) number K854042. 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 RESIN TRAY IMPRESSION MATERIAL?

RESIN TRAY IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1985-11-07. The listed applicant is Dentsply Intl.. The 510(k) number is K854042.

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

RESIN TRAY IMPRESSION MATERIAL received FDA 510(k) clearance on 1985-11-07, under 510(k) number K854042.

Who is the listed applicant for RESIN TRAY IMPRESSION MATERIAL?

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

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

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

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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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