Cleared Traditional

K982925 - LAMINOSS DENTAL IMPLANT

K982925 is the FDA 510(k) clearance for LAMINOSS DENTAL IMPLANT by Impladent , Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K982925 · Impladent , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
271d
Days
Class 2
Risk

K982925 is an FDA 510(k) clearance for the LAMINOSS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Impladent , Ltd. (Hollis, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 271 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 Impladent , Ltd. devices

Submission Details

510(k) Number K982925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1998
Decision Date May 18, 1999
Days to Decision 271 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 127d · This submission: 271d
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 423
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K982925.
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · Institut Straumann AG · Feb 2002
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · Institut Straumann AG · Dec 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
ITI DENTAL IMPLANT SYSTEM
K983742 · Institut Straumann AG · Mar 1999
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
NOBLEPHARMA WIDE ACCESSORIES
K962403 · Nobelpharma USA, Inc. · Sep 1996