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FDA 510(k)

TERUMO DENTAL NEEDLES

K-Number: K864970 · 1987-03-10

ApplicantTerumo Medical Corp.
Decision Date1987-03-10
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TERUMO DENTAL NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K864970. 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 TERUMO DENTAL NEEDLES?

TERUMO DENTAL NEEDLES is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Terumo Medical Corp.. The 510(k) number is K864970.

When did TERUMO DENTAL NEEDLES receive FDA 510(k) clearance?

TERUMO DENTAL NEEDLES received FDA 510(k) clearance on 1987-03-10, under 510(k) number K864970.

Who is the listed applicant for TERUMO DENTAL NEEDLES?

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

What is the FDA product code for TERUMO DENTAL NEEDLES?

The FDA product code for TERUMO DENTAL NEEDLES is DZM.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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