FIXTEMP C&B— 510(k) K102917

Substantially Equivalent

Exacta Dental Direct, Inc.

FDA 510(k) clearance K102917 for FIXTEMP C&B, Substantially Equivalent on 2011-06-17. Applicant: Exacta Dental Direct, Inc.. Device class: 2.

Clearance details

Applicant: Exacta Dental Direct, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2010-10-01
Decision date: 2011-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from Exacta Dental Direct, Inc.

K142446 — Fixtemp Cement2015-06-04

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