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FDA 510(k)

ZEST ENDODONTIC STABILIZER

K-Number: K801525 · 1980-07-21

ApplicantZest Anchors, Inc.
Decision Date1980-07-21
Product CodeELS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZEST ENDODONTIC STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801525. The device is classified under product code ELS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEST ENDODONTIC STABILIZER?

ZEST ENDODONTIC STABILIZER is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Zest Anchors, Inc.. The 510(k) number is K801525.

When did ZEST ENDODONTIC STABILIZER receive FDA 510(k) clearance?

ZEST ENDODONTIC STABILIZER received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801525.

Who is the listed applicant for ZEST ENDODONTIC STABILIZER?

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

What is the FDA product code for ZEST ENDODONTIC STABILIZER?

The FDA product code for ZEST ENDODONTIC STABILIZER is ELS.

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Other records listing Zest Anchors, 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.

K083324LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEMK072878MODIFICATION TO: LOCATOR IMPLANT ANCHORK042466X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALEK033699LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586K994257LOCATOR IMPLANT ANCHORK925849ZEST IMPLANT ANCHOR

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Related Devices (Code: ELS)

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.

K972985SPLINT ITJeneric/Pentron, Inc.K961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEMDentatus USA , Ltd.K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.K834363ENDIX RADICULAR BIOCERAMIC PINC.B.S. Biotechnics, Inc.K811209JACOB WIRZ TRANSFIXATION PINColmed, Ltd.

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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