Cleared Traditional

K934126 - ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS

K934126 is an FDA 510(k) clearance for ONE AND TWO PIECE TEMPORARY HEALING, manufactured by Implant Innovations, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K934126

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.

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 1186
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K934126.
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · Implant Innovations International, Inc. · May 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