Cleared Traditional

K862292 - ESPE VISIO-MOLAR

K862292 is an FDA 510(k) clearance for ESPE VISIO-MOLAR, 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 62-day FDA review.

K862292 · Espe GmbH (Us) · Dental device
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Aug 1986
Decision
62d
Days
Class 2
Risk

K862292 is an FDA 510(k) clearance for the ESPE VISIO-MOLAR. 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 August 18, 1986 after a review of 62 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K862292

510(k) Number K862292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date August 18, 1986
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
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 K862292.
MULTIFIL(R) VS
K863315 · Kulzer, Inc. · Sep 1986
DENTAL COMPOSITE RESTORATIVE
K863092 · Dentsply Intl. · Sep 1986
PHOTO CLEARFIL BRIGHT
K862942 · Kuraray Co. · Sep 1986
PANAVIA TC, AND PANAVIA OPAQUE
K862232 · Kuraray Co. · Jul 1986
DEN-MAT DENTIN LINK
K862449 · Den-Mat Corp. · Jul 1986
V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
K862648 · Scientific Pharmaceuticals, Inc. · Jul 1986