Cleared Traditional

K974738 - ASTRA TECH IMPLANT DENTAL SYSTEM

K974738 is the FDA 510(k) clearance for ASTRA TECH IMPLANT DENTAL SYSTEM by Astra Tech, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K974738 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
335d
Days
Class 2
Risk

K974738 is an FDA 510(k) clearance for the ASTRA TECH IMPLANT DENTAL SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Lexington, US). The FDA issued a Cleared decision on November 19, 1998 after a review of 335 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 Astra Tech, Inc. devices

Submission Details

510(k) Number K974738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date November 19, 1998
Days to Decision 335 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 127d · This submission: 335d
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 467
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K974738.
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · Institut Straumann AG · Mar 1999
OSSEOTITE DENTAL IMPLANTS
K983347 · Implant Innovations, Inc. · Jan 1999
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
DENTAL/SURGICAL DRILLS, BURS, TAPS
K973771 · Implant Innovations, Inc. · Dec 1997