Cleared Traditional

K121824 - ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2

K121824 is an FDA 510(k) clearance for ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIU..., manufactured by Lascod Spa. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K121824 · Lascod Spa · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
63d
Days
Class 2
Risk

K121824 is an FDA 510(k) clearance for the ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Lascod Spa (Mt. Airy, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lascod Spa devices

FDA 510(k) Submission Details - K121824

510(k) Number K121824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2012
Decision Date August 23, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K121824.
TAKE 1 ADVANCE
K130869 · Sybron Dental Specialties · May 2013
FLASH AR PENTA / FLASH AR PENTA QUICK
K131404 · 3M Deutschland GmbH · May 2013
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
K130647 · Heraeus Kulzer, LLC · May 2013
FLEXITIME FAST & SCAN LIGHT FLOW
K120914 · Heraeus Kulzer, LLC · Jul 2012
FLEXITIME MONOPHASE PRO SCAN
K113574 · Heraeus Kulzer, LLC · Jul 2012
TEMPSPAN CLEAR MATRIX
K120013 · Pentron Clinical · May 2012