Cleared Traditional

K904450 - BIOCERAM DENTAL IMPLANT, SERIES II

K904450 is an FDA 510(k) clearance for BIOCERAM DENTAL IMPLANT, manufactured by Kyocera America, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K904450 · Kyocera America, Inc. · Dental device
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Jul 1991
Decision
284d
Days
Class 2
Risk

K904450 is an FDA 510(k) clearance for the BIOCERAM DENTAL IMPLANT, SERIES II. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Kyocera America, Inc. (San Diego, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 284 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 Kyocera America, Inc. devices

FDA 510(k) Submission Details - K904450

510(k) Number K904450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date July 09, 1991
Days to Decision 284 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 127d · This submission: 284d
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 1328
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K904450.
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