Cleared Traditional

K071070 - OLYMPUS DENTAL IMPLANT SYSTEM

K071070 is an FDA 510(k) clearance for OLYMPUS DENTAL IMPLANT SYSTEM, manufactured by Keystone Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K071070 · Keystone Dental, Inc. · Dental device
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Oct 2007
Decision
190d
Days
Class 2
Risk

K071070 is an FDA 510(k) clearance for the OLYMPUS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Keystone Dental, Inc. (San Diego, US). The FDA issued a Cleared decision on October 23, 2007 after a review of 190 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 Keystone Dental, Inc. devices

FDA 510(k) Submission Details - K071070

510(k) Number K071070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date October 23, 2007
Days to Decision 190 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 127d · This submission: 190d
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 766
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K071070.
SPI SYSTEM DENTAL IMPLANTS
K072649 · Thommen Medical AG · Dec 2007
SPI CONTACT PLATFORM O 4.0 MM
K072933 · Thommen Medical AG · Nov 2007
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007
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K072768 · Lifecore Biomedical, Inc. · Oct 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · BioHorizons Implant Systems, Inc. · Oct 2007
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
K072589 · Zimmer Dental, Inc. · Oct 2007