Cleared Traditional

K993595 - NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)

K993595 is an FDA 510(k) clearance for NOBEL BIOCARE'S MODIFIED SURFACE IMPLAN..., manufactured by Nobel Biocare Uas, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K993595 · Nobel Biocare Uas, Inc. · Dental device
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Jan 2000
Decision
95d
Days
Class 2
Risk

K993595 is an FDA 510(k) clearance for the NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on January 28, 2000 after a review of 95 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 Nobel Biocare Uas, Inc. devices

FDA 510(k) Submission Details - K993595

510(k) Number K993595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date January 28, 2000
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
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 1243
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K993595.
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K993560 · Friadent GmbH · Jan 2000
FRIALIT-2 SELECT COMPONENTS
K993095 · Friadent GmbH · Dec 1999