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FDA 510(k)

POLYESTER RESIN HAND MOLDED TRAY

K-Number: K912820 · 1991-08-21

ApplicantE&D Dental Products, Inc.
Decision Date1991-08-21
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYESTER RESIN HAND MOLDED TRAY is the device name listed in this FDA 510(k) record. The listed applicant is E&D Dental Products, Inc.. It received FDA 510(k) clearance on 1991-08-21 under 510(k) number K912820. 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 POLYESTER RESIN HAND MOLDED TRAY?

POLYESTER RESIN HAND MOLDED TRAY is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is E&D Dental Products, Inc.. The 510(k) number is K912820.

When did POLYESTER RESIN HAND MOLDED TRAY receive FDA 510(k) clearance?

POLYESTER RESIN HAND MOLDED TRAY received FDA 510(k) clearance on 1991-08-21, under 510(k) number K912820.

Who is the listed applicant for POLYESTER RESIN HAND MOLDED TRAY?

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

What is the FDA product code for POLYESTER RESIN HAND MOLDED TRAY?

The FDA product code for POLYESTER RESIN HAND MOLDED TRAY is EBH.

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Other records listing E&D 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.

K953592REVOLUTION BONDK922633CAVI-ZYME

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.K905058PALAVIT LKulzer, Inc.K902350PALATRAY LC RESIN IMPRESSION TRAY MATERIALKulzer, Inc.

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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