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FDA 510(k)

NIPRO DENTAL NEEDLE

K-Number: K894373 · 1989-10-13

ApplicantPharma-Plast USA, Inc.
Decision Date1989-10-13
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NIPRO DENTAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast USA, Inc.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K894373. 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 NIPRO DENTAL NEEDLE?

NIPRO DENTAL NEEDLE is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Pharma-Plast USA, Inc.. The 510(k) number is K894373.

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

NIPRO DENTAL NEEDLE received FDA 510(k) clearance on 1989-10-13, under 510(k) number K894373.

Who is the listed applicant for NIPRO DENTAL NEEDLE?

The FDA 510(k) record lists Pharma-Plast USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIPRO DENTAL NEEDLE?

The FDA product code for NIPRO 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 Pharma-Plast USA, 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.

K894371NIPRO SAFELET CATHK894374BLOOD DRAWING NEEDLEK894372NIPRO NEEDLE HOLDERK884978PHARMA-PLAST INSULIN INFUSION SETK871263MULTIPLE PHARMA-PLAST TRACHEAL TUBEK852443PHARMA-PLAST CLINIPAK

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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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