Cleared Traditional

K214076 - EsCem

K214076 is an FDA 510(k) clearance for EsCem, manufactured by Spident Co., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K214076 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
357d
Days
Class 2
Risk

K214076 is an FDA 510(k) clearance for the EsCem. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Gojan-Dong, Namdong-Gu, KR). The FDA issued a Cleared decision on December 19, 2022 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Spident Co., Ltd. devices

FDA 510(k) Submission Details - K214076

510(k) Number K214076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date December 19, 2022
Days to Decision 357 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 127d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 309
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