Cleared Traditional

K103346 - DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

K103346 is an FDA 510(k) clearance for DELIKIT PUTTY, manufactured by Sherpa Korea. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K103346 · Sherpa Korea · Dental device
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Feb 2011
Decision
88d
Days
Class 2
Risk

K103346 is an FDA 510(k) clearance for the DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sherpa Korea (Hudson, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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.

FDA 510(k) Submission Details - K103346

510(k) Number K103346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date February 11, 2011
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 370
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K103346.
IMPRESSION COMPOUND
K110378 · Spofadental · Apr 2011
IOS FASTSCAN SPRAY
K103586 · Ios Technnologies, Inc. · Mar 2011
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
BONASIL A+ IMPRESSION MATERIALS
K102836 · Dmp, Ltd. · Jan 2011
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
K102770 · Heraeus Kulzer, LLC · Dec 2010
HYDROCOLOR 5
K102739 · Cascades Device Consulting Associates · Dec 2010
K103346 · DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
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