Cleared Traditional

PALGARAPID (K892839) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K892839 · Espe GmbH (Us) · Dental device
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Oct 1989
Decision
192d
Days
Class 2
Risk

K892839 is an FDA 510(k) clearance for the PALGARAPID. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 192 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K892839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date October 27, 1989
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 127d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K892839.
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · Dentsply Intl. · Mar 1989
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690 · 3M Company · Aug 1988