HI TECH IMPLANT, HT PHYSIO IMPLANT— 510(k) K091913

Name: FDA 510(k) clearance K091913
Creator: U.S. Food and Drug Administration
Published: 2009-10-30

Substantially Equivalent

By Dental Srl

FDA 510(k) clearance K091913 for HI TECH IMPLANT, HT PHYSIO IMPLANT, Substantially Equivalent on 2009-10-30. Applicant: By Dental Srl. Device class: 1.

Clearance details

Applicant: By Dental Srl
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-06-30
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Serravalle Poli; Pistoia, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKX

view all

K261987 — Reusable SmartPeg2026-09-08
K252223 — Alpha Endo Handpiece (Alpha Endo)2025-10-16
K251597 — InnerView System2025-09-18
K243692 — EnDrive (EnDriveUS)2025-08-22
K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)2025-04-24

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