Cleared Traditional

K003191 - MIS IMPLANT SYSTEM DECIVE

K003191 is an FDA 510(k) clearance for MIS IMPLANT SYSTEM DECIVE, manufactured by Mis Implants Technologies , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K003191 · Mis Implants Technologies , Ltd. · Dental device
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Sep 2001
Decision
353d
Days
Class 2
Risk

K003191 is an FDA 510(k) clearance for the MIS IMPLANT SYSTEM DECIVE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mis Implants Technologies , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 28, 2001 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K003191

510(k) Number K003191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date September 28, 2001
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 128d · This submission: 353d
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 1549
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003191.
SCREW VENT IMPLANT
K013227 · Sulzer Dental, Inc. · Nov 2001
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
K011502 · Crystal-Seal Dental Implants · Oct 2001
OMNICARE DENTAL IMPLANT SYSTEM
K000035 · Omnicare Dental Implant Center · Sep 2001
UNIVERSAL DENTAL COPING (UDC)
K010467 · Paxmed International · Sep 2001
UCLA AND UNIVERSAL ABUTMENTS
K010619 · Diamodent · Sep 2001
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K010882 · Blue Sky Bio · Sep 2001
K003191 · MIS IMPLANT SYSTEM DECIVE
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