Cleared Traditional

THE O-RING SYSTEM - ORS (K900099) - FDA 510(k) Clearance

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

K900099 · Attachments Intl., Inc. · Dental device
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Jan 1991
Decision
372d
Days
Class 2
Risk

K900099 is an FDA 510(k) clearance for the THE O-RING SYSTEM - ORS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Attachments Intl., Inc. (San Mateo, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 372 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.

View all Attachments Intl., Inc. devices

Submission Details

510(k) Number K900099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1990
Decision Date January 15, 1991
Days to Decision 372 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
245d slower than avg
Panel avg: 127d · This submission: 372d
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.