Cleared Traditional

K011785 - NOVEL PRINT CYAN ALGINATES

K011785 is an FDA 510(k) clearance for NOVEL PRINT CYAN ALGINATES, manufactured by Manufacturera Dental Continental. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011785 · Manufacturera Dental Continental · Dental device
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Sep 2001
Decision
88d
Days
Class 2
Risk

K011785 is an FDA 510(k) clearance for the NOVEL PRINT CYAN ALGINATES. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Manufacturera Dental Continental (Laguna Niguel, US). The FDA issued a Cleared decision on September 4, 2001 after a review of 88 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 Manufacturera Dental Continental devices

FDA 510(k) Submission Details - K011785

510(k) Number K011785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date September 04, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 284
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K011785.
XANTALGIN CRONO
K013336 · Cavex Holland BV · Oct 2001
STATUSBLUE
K013237 · Dmg USA, Inc. · Oct 2001
LUXABITE
K013236 · Dmg USA, Inc. · Oct 2001
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
CAVEX STABISIL
K011452 · Cavex Holland BV · Jul 2001
CAVEX COLORCHANGE
K011419 · Cavex Holland BV · Jul 2001