PTM SYSTEM— 510(k) K041335

Substantially Equivalent

Dentsply International

FDA 510(k) clearance K041335 for PTM SYSTEM, Substantially Equivalent on 2004-06-16. Applicant: Dentsply International. Device class: 2.

Clearance details

Applicant: Dentsply International
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2004-05-18
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Dentsply International

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.