Cleared Traditional

K060684 - ADPER PROMPT

K060684 is an FDA 510(k) clearance for ADPER PROMPT, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K060684 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
40d
Days
Class 2
Risk

K060684 is an FDA 510(k) clearance for the ADPER PROMPT, ADPER PROMPT L-POP. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on April 24, 2006 after a review of 40 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 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K060684

510(k) Number K060684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date April 24, 2006
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K060684.
BOSWORTH DENTIN RESIN
K061611 · Harry J. Bosworth Co. · Sep 2006
EXCEL BOND DC, MODEL 28-200100
K060882 · J. Morita USA, Inc. · Sep 2006
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
OPTIBOND ALL-IN-ONE
K060469 · Sybron Dental Specialties, Inc. · Mar 2006
FUTURABOND NR SINGLE DOSE
K053392 · Voco GmbH · Dec 2005
MULTIPLE RESIN TOOTH BONDING AGENT
K052501 · Cosmedent, Inc. · Oct 2005