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FDA 510(k)

OXY CUSTOM TRAY RESIN

K-Number: K801780 · 1980-08-07

ApplicantOxy Dental Products, Inc.
Decision Date1980-08-07
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OXY CUSTOM TRAY RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Oxy Dental Products, Inc.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801780. 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 OXY CUSTOM TRAY RESIN?

OXY CUSTOM TRAY RESIN is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Oxy Dental Products, Inc.. The 510(k) number is K801780.

When did OXY CUSTOM TRAY RESIN receive FDA 510(k) clearance?

OXY CUSTOM TRAY RESIN received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801780.

Who is the listed applicant for OXY CUSTOM TRAY RESIN?

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

What is the FDA product code for OXY CUSTOM TRAY RESIN?

The FDA product code for OXY CUSTOM TRAY RESIN is EBH.

Related Clinical Trials

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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Other records listing Oxy Dental Products, 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.

K801779OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT

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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