Cleared Traditional

ANSWER DENTAL IMPLEMENT, EXPLORER (K894896) - FDA 510(k) Clearance

Class I Dental device.

K894896 · Tern Chien Ent. Co., Ltd. · Dental device
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Oct 1989
Decision
90d
Days
Class 1
Risk

K894896 is an FDA 510(k) clearance for the ANSWER DENTAL IMPLEMENT, EXPLORER. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Tern Chien Ent. Co., Ltd. (Findlay, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Tern Chien Ent. Co., Ltd. devices

Submission Details

510(k) Number K894896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date October 30, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKJ Burnisher, Operative

Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K894896.
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