Cleared Traditional

K771327 - UVIOFIL

K771327 is an FDA 510(k) clearance for UVIOFIL, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K771327 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1977
Decision
15d
Days
Class 2
Risk

K771327 is an FDA 510(k) clearance for the UVIOFIL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K771327

510(k) Number K771327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1977
Decision Date August 02, 1977
Days to Decision 15 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
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 106
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K771327.
FISSURE SEALER AND BONDING AGENT
K790788 · Scientific Pharmaceuticals, Inc. · Jul 1979
ENAMEL BOND SYSTEM
K790596 · Wallace A. Erickson & Co. · Jun 1979
NUVA-COTE (MODIFICATION TO)
K771402 · L.D. Caulk Co. · Aug 1977
SEALANT, NEW FILLED
K760405 · L.D. Caulk Co. · Aug 1976
9075
K760418 · Lee Pharmaceuticals · Aug 1976