Cleared Traditional

K931767 - ASTRA TECH IMPLANTS-DENTAL SYSTEM

K931767 is the FDA 510(k) clearance for ASTRA TECH IMPLANTS-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 306-day FDA review.

K931767 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
306d
Days
Class 2
Risk

K931767 is an FDA 510(k) clearance for the ASTRA TECH IMPLANTS-DENTAL SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Waltham, US). The FDA issued a Cleared decision on February 8, 1994 after a review of 306 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 K931767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date February 08, 1994
Days to Decision 306 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
179d slower than avg
Panel avg: 127d · This submission: 306d
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 K931767.
STRYKER PRECISION DENTAL IMPLANT SYSTEM
K921805 · Stryker Instruments · Mar 1994
CONICAL ABUTMENT
K933462 · Implant Innovations, Inc. · Mar 1994
BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND
K925776 · Nobelpharma USA, Inc. · Feb 1994
BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP.
K925767 · Nobelpharma USA, Inc. · Oct 1993
NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE
K933150 · Nobelpharma USA, Inc. · Oct 1993
NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS
K925487 · Nobelpharma USA, Inc. · Oct 1993