Cleared Traditional

K093595 - CERAROOT IMPLANT SYSTEM

K093595 is an FDA 510(k) clearance for CERAROOT IMPLANT SYSTEM, manufactured by Oral Iceberg S.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K093595 · Oral Iceberg S.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
411d
Days
Class 2
Risk

K093595 is an FDA 510(k) clearance for the CERAROOT IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Oral Iceberg S.L. (Austin, US). The FDA issued a Cleared decision on January 4, 2011 after a review of 411 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K093595

510(k) Number K093595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2009
Decision Date January 04, 2011
Days to Decision 411 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 128d · This submission: 411d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K093595.
NEODENT IMPLANT SYSTEM
K101945 · Jjgc Industria E Comercio DE Materiais Dentarios S · Jan 2011
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
K101225 · Promimic AB · Jan 2011
IMPLANT-ONE SYSTEM
K102822 · Custom Dental Implants, Inc. · Jan 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
COWELL IMPLANT SYSTEM
K100850 · Cowellmedi Co., Ltd. · Dec 2010
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
K102981 · Ace Surgical Supply Company, Inc. · Dec 2010
K093595 · CERAROOT IMPLANT SYSTEM
Download PDF FDA Summary Oral Iceberg S.L.