Cleared Traditional

K934126 - ONE AND TWO PIECE TEMPORARY HEALING

K934126 is the FDA 510(k) clearance for ONE AND TWO PIECE TEMPORARY HEALING by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K934126 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
243d
Days
Class 2
Risk

K934126 is an FDA 510(k) clearance for the ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 243 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 Implant Innovations, Inc. devices

Submission Details

510(k) Number K934126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date April 25, 1994
Days to Decision 243 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
116d slower than avg
Panel avg: 127d · This submission: 243d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K934126.
BRANEMARK SYSTEM TEMPORARY SOLUTIONS
K925766 · Nobelpharma USA, Inc. · Aug 1994
BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276
K925483 · Nobelpharma USA, Inc. · May 1994
TAPERED ABUTMENT AND RELATED COMPONENTS
K933969 · Implant Innovations, Inc. · Apr 1994
STRYKER PRECISION DENTAL IMPLANT SYSTEM
K921805 · Stryker Instruments · Mar 1994
CONICAL ABUTMENT
K933462 · Implant Innovations, Inc. · Mar 1994
MINIBALL ABUTMENT
K930155 · Steri-Oss, Inc. · Feb 1994