Cleared Traditional

K980460 - ONPLANT ORTHODONTIC SYSTEM

K980460 is the FDA 510(k) clearance for ONPLANT ORTHODONTIC SYSTEM by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K980460 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
92d
Days
Class 2
Risk

K980460 is an FDA 510(k) clearance for the ONPLANT ORTHODONTIC SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Westmont, US). The FDA issued a Cleared decision on May 5, 1998 after a review of 92 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 K980460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date May 05, 1998
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 K980460.
OSSEOTITE DENTAL IMPLANTS
K983347 · Implant Innovations, Inc. · Jan 1999
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · Nobel Biocare Uas, Inc. · May 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
BRANEMARK SYSTEM(R) EBON(TM) FIXTURE
K974828 · Nobel Biocare Uas, Inc. · Mar 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · Steri-Oss, Inc. · Mar 1998