Cleared Traditional

K771627 - PERMAGUM

K771627 is the FDA 510(k) clearance for PERMAGUM by Espe GmbH (Us). It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K771627 · Espe GmbH (Us) · Dental device
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Sep 1977
Decision
7d
Days
Class 2
Risk

K771627 is an FDA 510(k) clearance for the PERMAGUM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 7 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K771627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1977
Decision Date September 02, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 127d · This submission: 7d
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 167
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K771627.
REFLECT IMPRESSION MATERIAL
K781689 · Kerr Corporation (Danbury) · Nov 1978
REPROSIL
K781151 · Dentsply Intl. · Aug 1978
PERMAGUM ADHESIVE
K771853 · Espe GmbH (Us) · Oct 1977
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753 · Cutter Laboratories, Inc. · Oct 1976
CUTTER FLEX-SILICONE IMPRESSION MAT.
K760752 · Cutter Laboratories, Inc. · Oct 1976
CUTTER SIL-SILICONE IMPRESSION MAT
K760755 · Cutter Laboratories, Inc. · Oct 1976