Cleared Traditional

K902928 - DEVICE PART NUMBER DPI-1106 IMPLANT

K902928 is an FDA 510(k) clearance for DEVICE PART NUMBER DPI-1106 IMPLANT, manufactured by Minimatic Implant Technology. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K902928 · Minimatic Implant Technology · Dental device
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Jan 1991
Decision
210d
Days
Class 2
Risk

K902928 is an FDA 510(k) clearance for the DEVICE PART NUMBER DPI-1106 IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Minimatic Implant Technology (Deerfield Beach, US). The FDA issued a Cleared decision on January 29, 1991 after a review of 210 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 Minimatic Implant Technology devices

FDA 510(k) Submission Details - K902928

510(k) Number K902928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date January 29, 1991
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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 1288
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K902928.
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K900180 · Core-Vent Corp. · Feb 1991
CASTABLE ABUTMENTS
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INTERPORE CYLINDRICAL HEX IMPLANT
K904611 · Interpore Intl. · Feb 1991
BC 1220 ANALOG - IMPLANT BODY
K904711 · Minimatic Implant Technology · Jan 1991
CGA-112 COPING GOLD ALLOY
K903113 · Minimatic Implant Technology · Dec 1990
A-1101 CAST ABUTMENT
K903039 · Minimatic Implant Technology · Dec 1990