Cleared Traditional

K012681 - ANKYLOS

K012681 is an FDA 510(k) clearance for ANKYLOS, manufactured by Dentsply Ceramco. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 738-day FDA review.

K012681 · Dentsply Ceramco · Dental device
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Aug 2003
Decision
738d
Days
Class 2
Risk

K012681 is an FDA 510(k) clearance for the ANKYLOS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentsply Ceramco (Burlington, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 738 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.

View all Dentsply Ceramco devices

FDA 510(k) Submission Details - K012681

510(k) Number K012681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date August 22, 2003
Days to Decision 738 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
611d slower than avg
Panel avg: 127d · This submission: 738d
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 1104
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