RODIN Cement— 510(k) K251775

Substantially Equivalent

Belport Company, Inc., Gingi-Pak

FDA 510(k) clearance K251775 for RODIN Cement, Substantially Equivalent on 2025-09-02. Applicant: Belport Company, Inc., Gingi-Pak. Device class: 2.

Clearance details

Applicant: Belport Company, Inc., Gingi-Pak
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2025-06-10
Decision date: 2025-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, 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 Belport Company, Inc., Gingi-Pak

K260430 — Porcelain Etch Gel2026-04-10
K250279 — RC-SwiftPrep2025-07-02
K250222 — SDF Pro2025-05-07
K240688 — RODIN Titan 3D Resin2024-06-20
K231060 — ProMin Dental Desensitizing Gel2024-06-13

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