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FDA 510(k)

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE

K-Number: K851524 · 1985-09-23

ApplicantSpecialites Septodont
Decision Date1985-09-23
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K851524. 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 SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE?

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Specialites Septodont. The 510(k) number is K851524.

When did SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE receive FDA 510(k) clearance?

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE received FDA 510(k) clearance on 1985-09-23, under 510(k) number K851524.

Who is the listed applicant for SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE?

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

What is the FDA product code for SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE?

The FDA product code for SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE is DZM.

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Other records listing Specialites Septodont 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.

K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTK010415ISODANK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRA

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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.K910446STABIDENT LOCAL ANESTHESIA SYSTEMFairfax Dental, Inc.

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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