Cleared Traditional

K083496 - CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS...

K083496 is the FDA 510(k) clearance for CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS... by Altatec GmbH. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K083496 · Altatec GmbH · Dental device
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Jan 2009
Decision
66d
Days
Class 2
Risk

K083496 is an FDA 510(k) clearance for the CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec GmbH (San Diego, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 66 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 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

Submission Details

510(k) Number K083496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2008
Decision Date January 30, 2009
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 Peers - DZE Implant, Endosseous, Root-form

All 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083496.
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