Cleared Traditional

K061998 - PREMIER SELF-ETCHING BOND ENHANCER

K061998 is an FDA 510(k) clearance for PREMIER SELF-ETCHING BOND ENHANCER, manufactured by Premier Dental Products Co.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K061998 · Premier Dental Products Co. · Dental device
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Oct 2006
Decision
82d
Days
Class 2
Risk

K061998 is an FDA 510(k) clearance for the PREMIER SELF-ETCHING BOND ENHANCER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on October 4, 2006 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Premier Dental Products Co. devices

FDA 510(k) Submission Details - K061998

510(k) Number K061998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2006
Decision Date October 04, 2006
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K061998.
PEAK BOND, MODEL 5133
K063557 · Ultradent Products, Inc. · Dec 2006
HKBOND 2006
K063062 · Heraeus Kulzer, Inc. · Dec 2006
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K062713 · Ivoclar Vivadent, Inc. · Nov 2006
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K062382 · Kuraray Medical, Inc. · Sep 2006
BOSWORTH DENTIN RESIN
K061611 · Harry J. Bosworth Co. · Sep 2006
EXCEL BOND DC, MODEL 28-200100
K060882 · J. Morita USA, Inc. · Sep 2006