UNITY DENTAL CEMENT— 510(k) K900342

Substantially Equivalent

Whaledent Intl. Div. Ipco

FDA 510(k) clearance K900342 for UNITY DENTAL CEMENT, Substantially Equivalent on 1990-05-07. Applicant: Whaledent Intl. Div. Ipco. Device class: 2.

Clearance details

Applicant: Whaledent Intl. Div. Ipco
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1990-01-23
Decision date: 1990-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartsdale, NY, 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 Whaledent Intl. Div. Ipco

K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM1989-03-16

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