Cleared Traditional

K894895 - ANSWER DENTAL IMPLEMENTS, MIRROR

K894895 is an FDA 510(k) clearance for ANSWER DENTAL IMPLEMENTS, manufactured by Tern Chien Ent. Co., Ltd.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K894895 · Tern Chien Ent. Co., Ltd. · Dental device
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Oct 1989
Decision
90d
Days
Class 1
Risk

K894895 is an FDA 510(k) clearance for the ANSWER DENTAL IMPLEMENTS, MIRROR. 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

FDA 510(k) Submission Details - K894895

510(k) Number K894895 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.

EKJ Device Classification - Class 1, General Controls

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

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K894895.
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990
RUBBER DAM CLAMPS/FORCEPS
K892261 · Zinnanti Surgical Instruments, Inc. · May 1989
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · Zinnanti Surgical Instruments, Inc. · May 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · Centrix, Inc. · Feb 1989