Cleared Traditional

K170104 - COMPACT S

K170104 is an FDA 510(k) clearance for COMPACT S, manufactured by Dmetec.Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K170104 · Dmetec.Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Dec 2017
Decision
349d
Days
Class 2
Risk

K170104 is an FDA 510(k) clearance for the COMPACT S, COMPACT S (LED). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dmetec.Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on December 27, 2017 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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. Elevated predicate reliance profile. 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 Dmetec.Co., Ltd. devices

FDA 510(k) Submission Details - K170104

510(k) Number K170104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date December 27, 2017
Days to Decision 349 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 127d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

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