Cleared Traditional

K903516 - BO-1121 BALL OVERDENTURE ATTACHMENT

K903516 is the FDA 510(k) clearance for BO-1121 BALL OVERDENTURE ATTACHMENT by Minimatic Implant Technology. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K903516 · Minimatic Implant Technology · Dental device
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Nov 1990
Decision
102d
Days
Class 2
Risk

K903516 is an FDA 510(k) clearance for the BO-1121 BALL OVERDENTURE ATTACHMENT. 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 November 13, 1990 after a review of 102 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 Minimatic Implant Technology devices

Submission Details

510(k) Number K903516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date November 13, 1990
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 675
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