Cleared Traditional

K970572 - DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET

K970572 is an FDA 510(k) clearance for DUAL INTEGRATOR DENTAL IMPLANT ACCESSOR..., manufactured by Implant Integration Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K970572 · Implant Integration Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
336d
Days
Class 2
Risk

K970572 is an FDA 510(k) clearance for the DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURG.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Integration Systems, Inc. (Paradise, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 336 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 Implant Integration Systems, Inc. devices

FDA 510(k) Submission Details - K970572

510(k) Number K970572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date January 16, 1998
Days to Decision 336 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 127d · This submission: 336d
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 K970572.
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