Cleared Traditional

K091907 - NOBELPROCERA IMPLANT BRIDGE ZIRCONIA

K091907 is the FDA 510(k) clearance for NOBELPROCERA IMPLANT BRIDGE ZIRCONIA by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K091907 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
103d
Days
Class 2
Risk

K091907 is an FDA 510(k) clearance for the NOBELPROCERA IMPLANT BRIDGE ZIRCONIA. 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 AB (Yorba Linda,, US). The FDA issued a Cleared decision on October 6, 2009 after a review of 103 days - within the typical 510(k) review window.

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: 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 AB devices

Submission Details

510(k) Number K091907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date October 06, 2009
Days to Decision 103 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
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K091907.
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
K092377 · Zimmer Dental, Inc. · Nov 2009
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
K092403 · Zimmer Dental, Inc. · Oct 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848 · Nobel Biocare AB · Oct 2009
NOBELPROCERA ZI ABUTMENT
K091904 · Nobel Biocare AB · Sep 2009
NOBELPROCERA TI ABUTMENT
K091756 · Nobel Biocare AB · Sep 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069 · Nobel Biocare AB · May 2009