Cleared Traditional

K193401 - Altatec GmbH CAMLOG/CONELOG PROGRESSIVE...

K193401 is the FDA 510(k) clearance for Altatec GmbH CAMLOG/CONELOG PROGRESSIVE... by Altatec GmbH. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K193401 · Altatec GmbH · Dental device
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Sep 2020
Decision
298d
Days
Class 2
Risk

K193401 is an FDA 510(k) clearance for the Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec GmbH (Wimsheim, DE). The FDA issued a Cleared decision on September 29, 2020 after a review of 298 days - an extended review cycle.

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: 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

Submission Details

510(k) Number K193401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date September 29, 2020
Days to Decision 298 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
171d slower than avg
Panel avg: 127d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

BioHorizons Implant Systems, Inc.
Bill Hornbuckle

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 - DZE Implant, Endosseous, Root-form

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