Endo Analyzer Model 8005 Modified

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K990225 ↗

FDA Product Code

EAT

Device Class

Class II

Regulation

21 CFR Part 872.1720

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K990898 Active Cleared 6 Apr 1999

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  FDA 510(k) K010940 Active Cleared 20 Jun 2001

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  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

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  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →

• What is the primary purpose of the Endo Analyzer Model 8005 Modified in dental procedures?

  The Endo Analyzer Model 8005 Modified is designed to assess tooth vitality and locate the apical foramen during endodontic treatments. It works by measuring electrical resistance within the dental pulp to help determine the anatomical endpoint for root canal therapy, ensuring accurate treatment depth.

• Is the Endo Analyzer Model 8005 Modified a single-use or reusable device, and how should it be maintained?

  The Endo Analyzer Model 8005 Modified is supplied as a reusable instrument. Since no specific sterility instructions are provided in the available data, it should be cleaned and maintained according to standard dental instrument protocols to ensure proper functionality and infection control.

• What power source does the Endo Analyzer Model 8005 Modified use, and is it compatible with standard dental office setups?

  The Endo Analyzer Model 8005 Modified is battery-operated, meaning it does not require direct electrical wiring. This makes it portable and suitable for use in standard dental offices without additional power infrastructure.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Endo Analyzer Model 8005 Modified received FDA 510(k) clearance (K990225) under the Traditional 510(k) pathway, classified as a Class II device under 21 CFR 872.1720. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device.