Cleared Traditional

K882566 - VISIO-PERL

K882566 is an FDA 510(k) clearance for VISIO-PERL, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K882566 · Espe GmbH (Us) · Dental device
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Oct 1988
Decision
119d
Days
Class 2
Risk

K882566 is an FDA 510(k) clearance for the VISIO-PERL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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

FDA 510(k) Submission Details - K882566

510(k) Number K882566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1988
Decision Date October 19, 1988
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K882566.
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
K884351 · Scientific Pharmaceuticals, Inc. · Dec 1988
SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED
K884352 · Scientific Pharmaceuticals, Inc. · Dec 1988
FIBERLITE, FIBERLITE HS AND FIBERSEAL
K884038 · Jeneric/Pentron, Inc. · Dec 1988
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · Scientific Pharmaceuticals, Inc. · Oct 1988
FORTIFY
K882915 · Bisco, Inc. · Aug 1988
PROSTHODENT VL
K881903 · Lee Pharmaceuticals · Jul 1988