Cleared Traditional

K854749 - STARTANIUS DENTAL IMPLANT SYSTEM

K854749 is an FDA 510(k) clearance for STARTANIUS DENTAL IMPLANT SYSTEM, manufactured by Park Dental Research Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K854749 · Park Dental Research Corp. · Dental device
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Mar 1986
Decision
100d
Days
Class 2
Risk

K854749 is an FDA 510(k) clearance for the STARTANIUS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Park Dental Research Corp. (New York, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 100 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.

View all Park Dental Research Corp. devices

FDA 510(k) Submission Details - K854749

510(k) Number K854749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1985
Decision Date March 06, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K854749.
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · Core-Vent Corp. · Nov 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · Interpore Intl. · Oct 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · Core-Vent Corp. · Oct 1986
IMZ INTRAMOBILE CYLINDER IMPLANT
K855032 · Interpore Intl. · Mar 1986
MONOJECT ENDOSSEOUS DENTAL IMPLANT
K781060 · Sherwood Medical Industries · Aug 1978