Cleared Traditional

K875091 - ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT

K875091 is an FDA 510(k) clearance for ORALIN TLC LIGHT CURED PIT AND FISSURE ..., manufactured by Mission White Dental, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K875091 · Mission White Dental, Inc. · Dental device
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Feb 1988
Decision
81d
Days
Class 2
Risk

K875091 is an FDA 510(k) clearance for the ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Mission White Dental, Inc. (Tinton Falls, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 81 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 Mission White Dental, Inc. devices

FDA 510(k) Submission Details - K875091

510(k) Number K875091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1987
Decision Date February 29, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 128d · This submission: 81d
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 109
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K875091.
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
TEETHMATE-A
K897027 · Kuraray Co. · Mar 1990
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K891140 · Coe Laboratories, Inc. · May 1989
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
BISCO PIT AND FISSURE SEALANT
K874556 · Bisco, Inc. · Jan 1988
BISCO PORCELAIN REPAIR KIT
K874557 · Bisco, Inc. · Jan 1988