Cleared Traditional

K962576 - SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM

K962576 is an FDA 510(k) clearance for SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM, manufactured by Calcitek, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K962576 · Calcitek, Inc. · Dental device
Download Printable Device Report (PDF)
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Feb 1997
Decision
224d
Days
Class 2
Risk

K962576 is an FDA 510(k) clearance for the SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 224 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 Calcitek, Inc. devices

FDA 510(k) Submission Details - K962576

510(k) Number K962576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date February 10, 1997
Days to Decision 224 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
97d slower than avg
Panel avg: 127d · This submission: 224d
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 1287
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K962576.
THREADLOC DENTAL IMPLANT SYSTEMS
K964768 · Sulzer Calcitek, Inc. · Feb 1997
LIFECORE CONICAL ABUTMENT
K965135 · Lifecore Biomedical, Inc. · Feb 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · Steri-Oss, Inc. · Feb 1997
ROUND DENTAL BUR
K964944 · Steri-Oss, Inc. · Feb 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330 · BioHorizons Implant Systems, Inc. · Jan 1997
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951 · BioHorizons Implant Systems, Inc. · Dec 1996