Cleared Special

K262983 - EsTemp Implant

K262983 is an FDA 510(k) clearance for EsTemp Implant, manufactured by Spident Co., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Special 510(k) pathway after a 29-day FDA review.

K262983 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
29d
Days
Class 2
Risk

K262983 is an FDA 510(k) clearance for the EsTemp Implant. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on September 25, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spident Co., Ltd. devices

FDA 510(k) Submission Details - K262983

510(k) Number K262983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2026
Decision Date September 25, 2026
Days to Decision 29 days
Submission Type Special
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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 445
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K262983.
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