Cleared Abbreviated

K111798 - STERNIC IMPLANT 4.2MM RN

K111798 is an FDA 510(k) clearance for STERNIC IMPLANT 4.2MM RN, manufactured by Sterngold Dental, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 340-day FDA review.

K111798 · Sterngold Dental, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
340d
Days
Class 2
Risk

K111798 is an FDA 510(k) clearance for the STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, .... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold Dental, LLC (Attleboro, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sterngold Dental, LLC devices

FDA 510(k) Submission Details - K111798

510(k) Number K111798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date June 01, 2012
Days to Decision 340 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 127d · This submission: 340d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 821
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K111798.
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
ET II BIO-SA FIXTURE SYSTEM
K112532 · Hiossen, Inc. · Aug 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012
SLIM ONEBODY SYSTEM
K111162 · Dentium Co., Ltd. · Jan 2012
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011