Cleared Traditional

K042658 - PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004

K042658 is an FDA 510(k) clearance for PROCERA ABUTMENT BRANEMARK, manufactured by Nobel Biocare Uas, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K042658 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
22d
Days
Class 2
Risk

K042658 is an FDA 510(k) clearance for the PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-600.... Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda,, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Nobel Biocare Uas, Inc. devices

FDA 510(k) Submission Details - K042658

510(k) Number K042658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2004
Decision Date October 20, 2004
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 669
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K042658.
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K043190 · Innova Life Sciences Corp. · Dec 2004
X-2 IMPLANT ABUTMENT
K042466 · Zest Anchors, Inc. · Nov 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042 · Nobel Biocare AB · Nov 2004
STRAUMANN TEMPORARY COPING
K041070 · The Straumann Co. · Jul 2004
PROCERA ABUTMENT OCTAGON
K041275 · Nobel Biocare Uas, Inc. · May 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236 · Nobel Biocare AB · May 2004