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FDA 510(k)

DENTI-TRAY(TM)

K-Number: K871493 · 1987-06-24

ApplicantAdvanced Medical, Inc.
Decision Date1987-06-24
Product CodeEKW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTI-TRAY(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical, Inc.. It received FDA 510(k) clearance on 1987-06-24 under 510(k) number K871493. The device is classified under product code EKW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTI-TRAY(TM)?

DENTI-TRAY(TM) is a medical device that received FDA 510(k) clearance on 1987-06-24. The listed applicant is Advanced Medical, Inc.. The 510(k) number is K871493.

When did DENTI-TRAY(TM) receive FDA 510(k) clearance?

DENTI-TRAY(TM) received FDA 510(k) clearance on 1987-06-24, under 510(k) number K871493.

Who is the listed applicant for DENTI-TRAY(TM)?

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

What is the FDA product code for DENTI-TRAY(TM)?

The FDA product code for DENTI-TRAY(TM) is EKW.

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 Advanced Medical, 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.

K884919DISPOSABLE DOME STOCK #D-300K760368MONITORING & STRESS TESTING EQUIPMENT

Related Devices (Code: EKW)

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.

K870765CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.K862523MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYSWalter Lorenz Surgical, Inc.K831749ENDODONTIC BROACH(76EKN) BARBED BROACHUnion BranchK823489ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.K800292ENDEX BROACH, ENDODONTICIpco Corp.K760985HAND INSTRUMENTSAdp Intl., 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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