DELTAPAL, ALLOY NO. 5161— 510(k) K993474

Name: FDA 510(k) clearance K993474
Creator: U.S. Food and Drug Administration
Published: 1999-12-02

Substantially Equivalent

Metalor Dental USA Corp.

FDA 510(k) clearance K993474 for DELTAPAL, ALLOY NO. 5161, Substantially Equivalent on 1999-12-02. Applicant: Metalor Dental USA Corp.. Device class: 2.

Clearance details

Applicant: Metalor Dental USA Corp.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1999-10-14
Decision date: 1999-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJS

view all

K041433 — BRIGHT GOLD XH2004-08-19
K040436 — SIMIDUR SUPERIOR2004-03-05
K022252 — STERNGOLD 1, MODEL 11277812002-09-19
K022469 — ECO E42002-09-18
K021367 — STERNGOLD 66, MODEL #11802302002-05-16

More clearances from Metalor Dental USA Corp.

view all

K003387 — AUROFILM NP2001-01-09
K993475 — AUROFLUID M, ALLOY NO. 53151999-12-09
K993505 — V-DELTA SPECIAL, ALLOY NO. 51541999-12-08
K993506 — PAGALINOR 4 , ALLOY NO. 54401999-12-08
K993507 — V-SUPRAGOLD, ALLOY NO. 50241999-12-06

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