Cleared Traditional

K863028 - ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY

K863028 is an FDA 510(k) clearance for ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMP..., manufactured by Ross Implant Technologies Corp., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K863028 · Ross Implant Technologies Corp., Inc. · Dental device
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Oct 1986
Decision
56d
Days
Class 2
Risk

K863028 is an FDA 510(k) clearance for the ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ross Implant Technologies Corp., Inc. (Washington, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ross Implant Technologies Corp., Inc. devices

FDA 510(k) Submission Details - K863028

510(k) Number K863028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1986
Decision Date October 06, 1986
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
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 1331
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K863028.
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
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · Calcitek, Inc. · Apr 1984
BIOLITE CARBON COATED DENTAL IMPLANT
K791491 · Carbomedics, Inc. · Sep 1979