EsTemp Implant— 510(k) K262983

Name: FDA 510(k) clearance K262983
Creator: U.S. Food and Drug Administration
Published: 2026-09-25

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K262983 for EsTemp Implant, Substantially Equivalent on 2026-09-25. Applicant: Spident Co., Ltd.. Device class: 2.

Summary

EsTemp Implant is a dental cement, product code EMA. The name suggests a temporary cement for implant-supported restorations, but the record doesn't state the indication.

Class II, 21 CFR 872.3275, Dental panel. Spident Co., Ltd. filed it as a Special 510(k).

Spident filed from Incheon, South Korea. The clock ran 29 days (August 27 to September 25, 2026).

Clearance details

Applicant: Spident Co., Ltd.
Product code: Product code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2026-08-27
Decision date: 2026-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.