Cleared Traditional

K853089 - SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE

K853089 is an FDA 510(k) clearance for SUPER ALGIN, manufactured by Psp Dental Co., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K853089 · Psp Dental Co., Ltd. · Dental device
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Apr 1986
Decision
272d
Days
Class 2
Risk

K853089 is an FDA 510(k) clearance for the SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Psp Dental Co., Ltd. (Belvedere, Kent, GB). The FDA issued a Cleared decision on April 21, 1986 after a review of 272 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Psp Dental Co., Ltd. devices

FDA 510(k) Submission Details - K853089

510(k) Number K853089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date April 21, 1986
Days to Decision 272 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 128d · This submission: 272d
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 332
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K853089.
VINYL POLYSILOXANE IMPRESSION SYSTEM
K871409 · Crown Delta Corp. · Jun 1987
HYDROPHILIC REPROSIL
K863288 · Dentsply Intl. · Dec 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL
K860911 · Austenal Dental, Inc. · Mar 1986
KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL
K860532 · Kerr Corporation (Danbury) · Mar 1986
IMPREGUM-F
K853529 · Espe GmbH (Us) · Mar 1986