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FDA 510(k)

DENTAL ANESTHESIA APPARATUS

K-Number: K850425 · 1986-10-09

ApplicantPain Prevention, Inc.
Decision Date1986-10-09
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

DENTAL ANESTHESIA APPARATUS is the device name listed in this FDA 510(k) record. The listed applicant is Pain Prevention, Inc.. It received FDA 510(k) clearance on 1986-10-09 under 510(k) number K850425. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DENTAL ANESTHESIA APPARATUS?

DENTAL ANESTHESIA APPARATUS is a medical device that received FDA 510(k) clearance on 1986-10-09. The listed applicant is Pain Prevention, Inc.. The 510(k) number is K850425.

When did DENTAL ANESTHESIA APPARATUS receive FDA 510(k) clearance?

DENTAL ANESTHESIA APPARATUS received FDA 510(k) clearance on 1986-10-09, under 510(k) number K850425.

Who is the listed applicant for DENTAL ANESTHESIA APPARATUS?

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

What is the FDA product code for DENTAL ANESTHESIA APPARATUS?

The FDA product code for DENTAL ANESTHESIA APPARATUS is KZM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , 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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