Cleared Traditional

K992538 - AMORPHOUS DIAMOND COATED SCREW

K992538 is the FDA 510(k) clearance for AMORPHOUS DIAMOND COATED SCREW by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K992538 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
116d
Days
Class 2
Risk

K992538 is an FDA 510(k) clearance for the AMORPHOUS DIAMOND COATED SCREW. 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 November 23, 1999 after a review of 116 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

Submission Details

510(k) Number K992538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date November 23, 1999
Days to Decision 116 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
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K992538.
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K994205 · Lifecore Biomedical, Inc. · Feb 2000
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)
K993595 · Nobel Biocare Uas, Inc. · Jan 2000
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · Implant Innovations, Inc. · Oct 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999
SYNOCTA PROSTHETICS
K990342 · Straumann USA · Jul 1999