Cleared Traditional

K152509 - CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

K152509 is an FDA 510(k) clearance for CAMLOG and CONELOG Abutments for Screw-..., 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 132-day FDA review.

K152509 · Altatec GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Jan 2016
Decision
132d
Days
Class 2
Risk

K152509 is an FDA 510(k) clearance for the CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR). 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 January 12, 2016 after a review of 132 days - within the typical 510(k) review window.

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: 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 Altatec GmbH devices

FDA 510(k) Submission Details - K152509

510(k) Number K152509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date January 12, 2016
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
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 653
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K152509.
KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
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Biodenta Customized Abutment - Titanium
K151295 · Biodenta Swiss AG · Dec 2015
OT EQUATOR
K142211 · Rhein 83 Srl · Nov 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · Prismatik Dentalcraft, Inc. · Nov 2015