Cleared Traditional

K050417 - ELITE IMPLANT

K050417 is an FDA 510(k) clearance for ELITE IMPLANT, manufactured by Zhermack S.P.A.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K050417 · Zhermack S.P.A. · Dental device
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Jul 2005
Decision
151d
Days
Class 2
Risk

K050417 is an FDA 510(k) clearance for the ELITE IMPLANT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack S.P.A. (Bend, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhermack S.P.A. devices

FDA 510(k) Submission Details - K050417

510(k) Number K050417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date July 19, 2005
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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 237
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K050417.
EXPASYL POWER APPLICATOR
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IMPRESSIX
K052455 · Cavex Holland BV · Nov 2005
FUTURE WASH/YPS
K051797 · 3M Espe AG Dental Products · Jul 2005
HYDROGUM 5
K051424 · Zhermack S.P.A. · Jul 2005
MODIFICATION TO:REGISTRADO X-TRA
K051535 · Voco GmbH · Jun 2005
CAVEX ORTHOTRACE
K051207 · Cavex Holland BV · Jun 2005