Cleared Traditional

K962403 - NOBLEPHARMA WIDE ACCESSORIES

K962403 is an FDA 510(k) clearance for NOBLEPHARMA WIDE ACCESSORIES, manufactured by Nobelpharma USA, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962403 · Nobelpharma USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
77d
Days
Class 2
Risk

K962403 is an FDA 510(k) clearance for the NOBLEPHARMA WIDE ACCESSORIES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on September 6, 1996 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K962403

510(k) Number K962403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date September 06, 1996
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K962403.
MT-2A
K961386 · The Emerging Technologies Group · Sep 1996
MT-X
K961387 · The Emerging Technologies Group · Sep 1996
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · Implant Innovations, Inc. · Sep 1996
OSTEO COMPACTION KIT
K962449 · Steri-Oss, Inc. · Sep 1996
SPLINE DENTAL IMPLANT SYSTEMS
K962106 · Calcitek, Inc. · Aug 1996
VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
K961861 · Implant Management of America · Aug 1996