Cleared Traditional

K992538 - AMORPHOUS DIAMOND COATED SCREW

K992538 is an FDA 510(k) clearance for AMORPHOUS DIAMOND COATED SCREW, 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 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

FDA 510(k) Submission Details - K992538

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.

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 1264
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K992538.
THE 4.5MM DIAMETER BICON DENTAL IMPLANT
K994037 · Bicon, Inc. · Jan 2000
FRIALIT-2 BONE PROFILER
K993560 · Friadent GmbH · Jan 2000
FRIALIT-2 SELECT COMPONENTS
K993095 · Friadent GmbH · Dec 1999
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA
K992512 · Imcor · Nov 1999
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · Implant Innovations, Inc. · Oct 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999