Cleared Abbreviated

K061500 - SICACE DENTAL IMPLANT SYSTEM AND SIC AN...

K061500 is an FDA 510(k) clearance for SICACE DENTAL IMPLANT SYSTEM AND SIC AN..., manufactured by Sic Invent AG. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 69-day FDA review.

K061500 · Sic Invent AG · Dental device
Download Printable Device Report (PDF)
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Aug 2006
Decision
69d
Days
Class 2
Risk

K061500 is an FDA 510(k) clearance for the SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sic Invent AG (Mühlheim An Der Donau, DE). The FDA issued a Cleared decision on August 8, 2006 after a review of 69 days - a notably fast clearance cycle.

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 Sic Invent AG devices

FDA 510(k) Submission Details - K061500

510(k) Number K061500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date August 08, 2006
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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 797
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061500.
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006
STRAUMANN DENTAL IMPLANTS
K061176 · Institut Straumann AG · Aug 2006
SFB & CFB IMPLANTS
K061003 · Nobel Biocare AB · Jun 2006
SPEEDY ORTHODONTIC SCREW
K060500 · Dentium Co., Ltd. · Jun 2006
IMPLANTIUM II
K060501 · Dentium Co., Ltd. · Jun 2006