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FDA 510(k)

STABIDENT LOCAL ANESTHESIA SYSTEM

K-Number: K910446 · 1991-06-03

ApplicantFairfax Dental, Inc.
Decision Date1991-06-03
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STABIDENT LOCAL ANESTHESIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fairfax Dental, Inc.. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K910446. The device is classified under product code DZM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STABIDENT LOCAL ANESTHESIA SYSTEM?

STABIDENT LOCAL ANESTHESIA SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Fairfax Dental, Inc.. The 510(k) number is K910446.

When did STABIDENT LOCAL ANESTHESIA SYSTEM receive FDA 510(k) clearance?

STABIDENT LOCAL ANESTHESIA SYSTEM received FDA 510(k) clearance on 1991-06-03, under 510(k) number K910446.

Who is the listed applicant for STABIDENT LOCAL ANESTHESIA SYSTEM?

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

What is the FDA product code for STABIDENT LOCAL ANESTHESIA SYSTEM?

The FDA product code for STABIDENT LOCAL ANESTHESIA SYSTEM is DZM.

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Related Devices (Code: DZM)

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.

K990511X-TIP INTRAOSSEOUS PERFORATORSchiff & Co.K920758JENKER NEEDLE STICK PROTECTORDentsply Intl.K914562ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEMAseptic Dental Technologies, Inc.K913573SAFETY PLUS DENTAL INJECTION NEEDLESpecialites SeptodontK910475DENTAL NEEDLE PROTECTIVE SYSTEMHealth Technology Systems, Inc.K896219SAFE-T-CAP NEEDLE COVERAusmedics Pty , Ltd.

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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