Cleared Traditional

K143337 - CONELOG Titanium base CAD/CAM

K143337 is an FDA 510(k) clearance for CONELOG Titanium base CAD/CAM, manufactured by Altatec GmbH. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K143337 · Altatec GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
89d
Days
Class 2
Risk

K143337 is an FDA 510(k) clearance for the CONELOG Titanium base CAD/CAM. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Altatec GmbH (Wimsheim, DE). The FDA issued a Cleared decision on February 17, 2015 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

View all Altatec GmbH devices

FDA 510(k) Submission Details - K143337

510(k) Number K143337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date February 17, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 Consultant

PaxMed International, LLC
LINDA K SCHULZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 652
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K143337.
CreoDent Solidex Customized Abutment
K150012 · Creodent Prosthetics, Ltd. · Jun 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · Zimmer Dental, Inc. · May 2015
MEDENTIKA ABUTMENT SYSTEM
K142167 · Medentika GmbH · Feb 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572 · Zimmer Dental, Inc. · Jan 2015
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
K142890 · Straumann USA, LLC · Jan 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
K141923 · Prismatik Dentalcraft, Inc. · Jan 2015