Cleared Traditional

DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL (K760008) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760008 · Kyocera International, Inc. · Dental device
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Oct 1976
Decision
119d
Days
Class 2
Risk

K760008 is an FDA 510(k) clearance for the DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Kyocera International, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1976 after a review of 119 days - within the typical 510(k) review window.

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 Kyocera International, Inc. devices

Submission Details

510(k) Number K760008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1976
Decision Date October 05, 1976
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
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.