Cleared Traditional

K873143 - ROS-TR SYSTEM

K873143 is an FDA 510(k) clearance for ROS-TR SYSTEM, manufactured by Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K873143 · Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn · Dental device
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Sep 1987
Decision
32d
Days
Class 2
Risk

K873143 is an FDA 510(k) clearance for the ROS-TR SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn (Washington, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn devices

FDA 510(k) Submission Details - K873143

510(k) Number K873143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date September 11, 1987
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 128d · This submission: 32d
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 1330
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K873143.
THE MICRO-VENT/HA
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K874400 · Implant Innovations International, Inc. · Mar 1988
VENT CORP PIB IMPLANT
K873818 · Core-Vent Corp. · Feb 1988
TEMPORARY BRIDGE HEAD
K871953 · Implant Innovations International, Inc. · Jul 1987
ABUTMENT HEAD POST
K871954 · Implant Innovations International, Inc. · Jul 1987
TEMPORARY SCREW
K871955 · Implant Innovations International, Inc. · Jul 1987