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FDA 510(k)

DENTRON-DIRECT-TRAY

K-Number: K820998 · 1982-06-10

ApplicantDentron, Inc.
Decision Date1982-06-10
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTRON-DIRECT-TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Dentron, Inc.. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K820998. 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 DENTRON-DIRECT-TRAY?

DENTRON-DIRECT-TRAY is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Dentron, Inc.. The 510(k) number is K820998.

When did DENTRON-DIRECT-TRAY receive FDA 510(k) clearance?

DENTRON-DIRECT-TRAY received FDA 510(k) clearance on 1982-06-10, under 510(k) number K820998.

Who is the listed applicant for DENTRON-DIRECT-TRAY?

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

What is the FDA product code for DENTRON-DIRECT-TRAY?

The FDA product code for DENTRON-DIRECT-TRAY 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 Dentron, 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.

K820997DENTRON-EXACT - TRAY

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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