ESTEMP IMPLANT, ESTEMP CLEAR— 510(k) K134021

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K134021 for ESTEMP IMPLANT, ESTEMP CLEAR, Substantially Equivalent on 2014-06-10. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2013-12-30
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lee, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Spident Co., Ltd.

K261129 — OrthoFit2026-07-02
K250566 — EsCem RMGI2025-06-20
K250317 — EsFlow PLUS2025-05-30
K242702 — VioSeal2024-11-07
K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)2024-11-01

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