Cleared Traditional

K944725 - KIS-II STR FIXTURES

K944725 is an FDA 510(k) clearance for KIS-II STR FIXTURES, manufactured by Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K944725 · Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
212d
Days
Class 2
Risk

K944725 is an FDA 510(k) clearance for the KIS-II STR FIXTURES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 212 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 Center of the Palm Beaches devices

FDA 510(k) Submission Details - K944725

510(k) Number K944725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date April 26, 1995
Days to Decision 212 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 127d · This submission: 212d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K944725.
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · Calcitek, Inc. · May 1995
INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING
K941608 · Calcitek, Inc. · May 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950446 · Steri-Oss, Inc. · May 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · Steri-Oss, Inc. · Apr 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681 · Steri-Oss, Inc. · Apr 1995
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
K945398 · Nobelpharma USA, Inc. · Apr 1995