# K973439: Endo Analyzer, Model 8005

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Dec 8, 1997 after 89 days
- Product code: EAT (Tester, Pulp)
- Device class: 2
- Regulation: 21 CFR 872.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Analytic Technology Corporation, Apex Finder A.F.A.: named in the summary without a submission number
- (no number) Analytic Technology Corporation, Vitality Scanner: named in the summary without a submission number

## Indications for use
The Endo Analyzer, Model 8005, is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

Source page: https://510kreport.com/device/K973439
Methodology: https://510kreport.com/methodology