Cleared Traditional

K970127 - EDOSSEOUS DENTAL IMPLANT

K970127 is an FDA 510(k) clearance for EDOSSEOUS DENTAL IMPLANT, 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 160-day FDA review.

K970127 · Sulzer Calcitek, Inc. · Dental device
Download Printable Device Report (PDF)
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Jun 1997
Decision
160d
Days
Class 2
Risk

K970127 is an FDA 510(k) clearance for the EDOSSEOUS DENTAL IMPLANT. 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 160 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 Sulzer Calcitek, Inc. devices

FDA 510(k) Submission Details - K970127

510(k) Number K970127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1997
Decision Date June 23, 1997
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
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 939
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K970127.
THE PERIOSEAL DENTAL IMPLANT
K965032 · Perioseal · Aug 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · Bicon, Inc. · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · Sulzer Calcitek, Inc. · Jun 1997
LIFECORE O-RING ABUTMENT
K970776 · Lifecore Biomedical, Inc. · May 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · Innova Corp. · May 1997