Cleared Traditional

K032708 - PLASTALGIN AND PLASTALGIN ORTHO

K032708 is an FDA 510(k) clearance for PLASTALGIN AND PLASTALGIN ORTHO, manufactured by Septodont. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K032708 · Septodont · Dental device
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Nov 2003
Decision
79d
Days
Class 2
Risk

K032708 is an FDA 510(k) clearance for the PLASTALGIN AND PLASTALGIN ORTHO. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 79 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 Septodont devices

FDA 510(k) Submission Details - K032708

510(k) Number K032708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date November 20, 2003
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
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 196
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K032708.
FLEXITIME XTREME
K042878 · Heraeus Kulzer, Inc. · Dec 2004
GC FUSION
K041398 · GC America, Inc. · Jun 2004
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
K041229 · Cosmedent, Inc. · Jun 2004
FIT CHECKER II
K032289 · GC America, Inc. · Oct 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · Harry J. Bosworth Co. · Oct 2003
TULIP COLORSWITCH
K032116 · Cavex Holland BV · Sep 2003