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FDA 510(k)

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

K-Number: K012427 · 2001-10-09

ApplicantSpecialites Septodont
Decision Date2001-10-09
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K012427. The device is classified under product code EAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT?

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is Specialites Septodont. The 510(k) number is K012427.

When did PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT receive FDA 510(k) clearance?

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT received FDA 510(k) clearance on 2001-10-09, under 510(k) number K012427.

Who is the listed applicant for PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT?

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

What is the FDA product code for PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT?

The FDA product code for PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT is EAT.

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Other records listing Specialites Septodont 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.

K010415ISODANK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRAK915467CIMPAT S DENTAL CEMENT

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Related Devices (Code: EAT)

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.

K022097THERMIQUEParkell, Inc.K021298ELEMENTS DIAGNOSTIC UNITSybron Endo/AnalyticK011666CHILLITHeatshield, Inc.K990225ENDO ANALYZER, MODEL 8005, MODIFIEDSybron Dental Specialties, Inc.K973439ENDO ANALYZER, MODEL 8005Sybron Dental Specialties, Inc.K970715SYSTEM B HEAT SOURCESybron Dental Specialties, 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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