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Model 6110B Dentaphor

by Life-Tech Intl., Inc.

510(k) K870118

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870118 Date10 Apr 1987ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EAT
Device Class
Class II
Regulation
21 CFR Part 872.1720
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 6110B Dentaphor is an electrical pulp tester used to assess dental pulp vitality. It employs high-frequency current delivered via an electrode to stimulate nerve tissue within the tooth pulp, helping clinicians evaluate the responsiveness and health of dental pulp.

This device is intended for use in dental offices and is powered by either AC or battery. It is classified as a Class II medical device under FDA regulations (Product Code EAT) and holds a 510(k) clearance (K870118) dated April 10, 1987. The device is designed for single-use or reusable applications, depending on manufacturer guidelines, and requires proper storage to maintain functionality.

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