Cleared Traditional

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K992518) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992518 · Dentsply Intl. · Dental device

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Sep 1999

Decision

56d

Days

Class 2

Risk

K992518 is an FDA 510(k) clearance for the PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 22, 1999 after a review of 56 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 Dentsply Intl. devices

Submission Details

510(k) Number	K992518 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 1999
Decision Date	September 22, 1999
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

71d faster than avg

Panel avg: 127d · This submission: 56d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 24

Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K992518.

SPK SEALANT

K091632 · 3M Company · Sep 2009

NRC NON-RINSE CONDITIONER

K992519 · Dentsply Intl. · Oct 1999

3M CLINPRO SEALANT

K992326 · 3M Company · Oct 1999

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT

K992516 · Dentsply Intl. · Aug 1999

DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT

K991909 · Dentsply Intl. · Aug 1999

DELTON FS DIRECT DELIVERY SYSTEM

K982564 · Dentsply Intl. · Oct 1998

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K992518

Dentsply Intl.

York, PA · US

P. JEFFERY LEHN

Regulatory profile

279 submissions 279 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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