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FDA 510(k)

DENTAL ROOT ELEVATOR

K-Number: K892255 · 1989-05-01

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-05-01
Product CodeEKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ROOT ELEVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K892255. The device is classified under product code EKO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL ROOT ELEVATOR?

DENTAL ROOT ELEVATOR is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K892255.

When did DENTAL ROOT ELEVATOR receive FDA 510(k) clearance?

DENTAL ROOT ELEVATOR received FDA 510(k) clearance on 1989-05-01, under 510(k) number K892255.

Who is the listed applicant for DENTAL ROOT ELEVATOR?

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

What is the FDA product code for DENTAL ROOT ELEVATOR?

The FDA product code for DENTAL ROOT ELEVATOR is EKO.

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Other records listing Zinnanti Surgical Instruments, 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.

K925501NYLON COATED SPECULAK941458UTERINE MANIPULATOR/INJECTOR WITH SPRINGK941457UTERINE INJECTOR WITH SPRINGK925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODESK925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEK925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE

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Related Devices (Code: EKO)

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.

K903672DENE BRIDGEDirotian Pty. , Ltd.K780722ADVANCED DENTURE SYSTEMAdvanced Marketing Research Co.K760768FLEXIDENT DENTUREFlexodent Corp.

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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