Cleared Traditional

K981997 - POSI-STOP/POSI-TRAC SYSTEM

K981997 is an FDA 510(k) clearance for POSI-STOP/POSI-TRAC SYSTEM, manufactured by The Dental Medical Device Co., LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K981997 · The Dental Medical Device Co., LLC · Dental device
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Jan 1999
Decision
218d
Days
Class 2
Risk

K981997 is an FDA 510(k) clearance for the POSI-STOP/POSI-TRAC SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Dental Medical Device Co., LLC (Montville, US). The FDA issued a Cleared decision on January 12, 1999 after a review of 218 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 The Dental Medical Device Co., LLC devices

FDA 510(k) Submission Details - K981997

510(k) Number K981997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date January 12, 1999
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K981997.
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · Nobel Biocare Uas, Inc. · Mar 1999
WIDE BODY ABUTMENTS
K984198 · Vident · Feb 1999
BICON BONE SCREW SYSTEM
K982488 · Bicon, Inc. · Jan 1999
IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I
K983563 · Imcor · Jan 1999
OSSEOTITE DENTAL IMPLANTS
K983347 · Implant Innovations, Inc. · Jan 1999
ASTRA TECH IMPLANT DENTAL SYSTEM
K974738 · Astra Tech, Inc. · Nov 1998