Cleared Traditional

K884140 - ROS-TR SYSTEM

K884140 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 164-day FDA review.

K884140 · Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn · Dental device
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Mar 1989
Decision
164d
Days
Class 2
Risk

K884140 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 March 13, 1989 after a review of 164 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 Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn devices

FDA 510(k) Submission Details - K884140

510(k) Number K884140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date March 13, 1989
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 128d · This submission: 164d
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 K884140.
INSERTION TOOLS
K891617 · Implant Innovations International, Inc. · May 1989
SURGICAL DRILLS
K891615 · Implant Innovations International, Inc. · Apr 1989
TITANIUM FORCEPS
K891618 · Implant Innovations International, Inc. · Apr 1989
IMZ O-RING ATTACHMENT
K883211 · Interpore Intl. · Nov 1988
INNOVATIVE IMPLANTS AND COVER SCREWS
K874590 · Implant Innovations International, Inc. · May 1988
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988