Cleared Traditional

HH-1119 HEALING HEAD (K903515) - FDA 510(k) Clearance

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

K903515 · Minimatic Implant Technology · Dental device
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Jul 1991
Decision
335d
Days
Class 2
Risk

K903515 is an FDA 510(k) clearance for the HH-1119 HEALING HEAD. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Minimatic Implant Technology (Deerfield Beach, US). The FDA issued a Cleared decision on July 4, 1991 after a review of 335 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: Standard predicate-based submission. Elevated predicate reliance profile. 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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Submission Details

510(k) Number K903515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date July 04, 1991
Days to Decision 335 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 127d · This submission: 335d
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.