Cleared Traditional

K970752 - SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM

K970752 is an FDA 510(k) clearance for SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM, manufactured by Sulzer Calcitek, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K970752 · Sulzer Calcitek, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
112d
Days
Class 2
Risk

K970752 is an FDA 510(k) clearance for the SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sulzer Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 23, 1997 after a review of 112 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K970752

510(k) Number K970752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date June 23, 1997
Days to Decision 112 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
16d faster than avg
Panel avg: 128d · This submission: 112d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K970752.
IMZ TWIN PLUS - CYLINDER
K963521 · Imz, GmbH · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · Sulzer Calcitek, Inc. · Jun 1997
LIFECORE O-RING ABUTMENT
K970776 · Lifecore Biomedical, Inc. · May 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753 · Biomedical Implant Technology, Inc. · May 1997
ODONT HEX SYSTEM
K961631 · Odontit S.A. · May 1997
K970752 · SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
Download PDF FDA Summary Sulzer Calcitek, Inc.