Cleared Traditional

K042614 - S&C-SELF ETCH PR-BOND

K042614 is an FDA 510(k) clearance for S&C-SELF ETCH PR-BOND, manufactured by S & C Polymer GmbH. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K042614 · S & C Polymer GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
59d
Days
Class 2
Risk

K042614 is an FDA 510(k) clearance for the S&C-SELF ETCH PR-BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Elmshorn, DE). The FDA issued a Cleared decision on November 22, 2004 after a review of 59 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 S & C Polymer GmbH devices

FDA 510(k) Submission Details - K042614

510(k) Number K042614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date November 22, 2004
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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 331
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K042614.
BC PLUS
K043562 · Vericom Co., Ltd. · Jan 2005
CLEARFIL TRI-S BOND
K042913 · Kuraray Medical, Inc. · Nov 2004
QUADRANT UNIT-1-BOND
K042806 · Cavex Holland BV · Nov 2004
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004
M.L. PRIMER
K040079 · Shofu Dental Corp. · Sep 2004
COMPOSITE/COMPOMER REPAIR KIT
K041960 · Dmg USA, Inc. · Aug 2004