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FDA 510(k)

EXEL DENTAL NEEDLE

K-Number: K861150 · 1986-04-11

ApplicantExel Intl.
Decision Date1986-04-11
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXEL DENTAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K861150. 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 EXEL DENTAL NEEDLE?

EXEL DENTAL NEEDLE is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Exel Intl.. The 510(k) number is K861150.

When did EXEL DENTAL NEEDLE receive FDA 510(k) clearance?

EXEL DENTAL NEEDLE received FDA 510(k) clearance on 1986-04-11, under 510(k) number K861150.

Who is the listed applicant for EXEL DENTAL NEEDLE?

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

What is the FDA product code for EXEL DENTAL NEEDLE?

The FDA product code for EXEL DENTAL NEEDLE is DZM.

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 Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)K903945EXEL A-V FISTULA SET

View all 18 devices →

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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