TEMPFX ESTHETIC PROVISIONAL SYSTEM— 510(k) K061264

Name: FDA 510(k) clearance K061264
Creator: U.S. Food and Drug Administration
Published: 2006-05-23

Substantially Equivalent

Dentsply International, Inc.

FDA 510(k) clearance K061264 for TEMPFX ESTHETIC PROVISIONAL SYSTEM, Substantially Equivalent on 2006-05-23. Applicant: Dentsply International, Inc.. Device class: 2.

Clearance details

Applicant: Dentsply International, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2006-05-05
Decision date: 2006-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

view all

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 Dentsply International, Inc.

view all

K160207 — ATLANTIS ISUS Implant Suprastructures2016-09-21
K160232 — Disposable Barrier Sleeves and Covers2016-06-07
K151439 — ATLANTIS ISUS2016-02-19
K152247 — ATLANTIS Crown2016-01-29
K151039 — ATLANTIS Abutment for NobelActive 3.02016-01-14

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