CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE— 510(k) K052097

Name: FDA 510(k) clearance K052097
Creator: U.S. Food and Drug Administration
Published: 2005-08-12

Substantially Equivalent

Dentsply International

FDA 510(k) clearance K052097 for CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE, Substantially Equivalent on 2005-08-12. Applicant: Dentsply International. Device class: 2.

Clearance details

Applicant: Dentsply International
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2005-08-03
Decision date: 2005-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Dentsply International

view all

K122268 — ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS2012-12-11
K061580 — ECLIPSE WAX REMOVER2006-07-28
K060837 — IN-OVATION C2006-04-10
K053368 — INTERPROXIMAL REDUCTION SYSTEM2006-03-29
K052370 — CP BRACKET SYSTEM2005-11-01

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