Cleared Traditional

K010619 - UCLA AND UNIVERSAL ABUTMENTS

K010619 is an FDA 510(k) clearance for UCLA AND UNIVERSAL ABUTMENTS, manufactured by Diamodent. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K010619 · Diamodent · Dental device
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Sep 2001
Decision
211d
Days
Class 2
Risk

K010619 is an FDA 510(k) clearance for the UCLA AND UNIVERSAL ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Diamodent (Anaheim, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 211 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.

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FDA 510(k) Submission Details - K010619

510(k) Number K010619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date September 28, 2001
Days to Decision 211 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 127d · This submission: 211d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010619.
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ITI DENTAL IMPLANT SYSTEM
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