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FDA 510(k)

DENTAL NEEDLE PROTECTIVE SYSTEM

K-Number: K910475 · 1991-09-13

ApplicantHealth Technology Systems, Inc.
Decision Date1991-09-13
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL NEEDLE PROTECTIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Health Technology Systems, Inc.. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K910475. 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 DENTAL NEEDLE PROTECTIVE SYSTEM?

DENTAL NEEDLE PROTECTIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Health Technology Systems, Inc.. The 510(k) number is K910475.

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

DENTAL NEEDLE PROTECTIVE SYSTEM received FDA 510(k) clearance on 1991-09-13, under 510(k) number K910475.

Who is the listed applicant for DENTAL NEEDLE PROTECTIVE SYSTEM?

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

What is the FDA product code for DENTAL NEEDLE PROTECTIVE SYSTEM?

The FDA product code for DENTAL NEEDLE PROTECTIVE SYSTEM is DZM.

Related Clinical Trials

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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 SeptodontK910446STABIDENT LOCAL ANESTHESIA SYSTEMFairfax Dental, 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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