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FDA 510(k)

QUAD IV CUSTOM IMPRESSION TRAY

K-Number: K790897 · 1979-06-15

ApplicantSted, Inc.
Decision Date1979-06-15
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUAD IV CUSTOM IMPRESSION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Sted, Inc.. It received FDA 510(k) clearance on 1979-06-15 under 510(k) number K790897. 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 QUAD IV CUSTOM IMPRESSION TRAY?

QUAD IV CUSTOM IMPRESSION TRAY is a medical device that received FDA 510(k) clearance on 1979-06-15. The listed applicant is Sted, Inc.. The 510(k) number is K790897.

When did QUAD IV CUSTOM IMPRESSION TRAY receive FDA 510(k) clearance?

QUAD IV CUSTOM IMPRESSION TRAY received FDA 510(k) clearance on 1979-06-15, under 510(k) number K790897.

Who is the listed applicant for QUAD IV CUSTOM IMPRESSION TRAY?

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

What is the FDA product code for QUAD IV CUSTOM IMPRESSION TRAY?

The FDA product code for QUAD IV CUSTOM IMPRESSION TRAY 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

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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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