Cleared Traditional

K091904 - NOBELPROCERA ZI ABUTMENT

K091904 is the FDA 510(k) clearance for NOBELPROCERA ZI ABUTMENT by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K091904 · Nobel Biocare AB · Dental device
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Sep 2009
Decision
92d
Days
Class 2
Risk

K091904 is an FDA 510(k) clearance for the NOBELPROCERA ZI ABUTMENT. 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 September 25, 2009 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 872.3630 - 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 K091904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date September 25, 2009
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 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 K091904.
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
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NOBEL/PROCERA IMPLANT BRIDGE
K091848 · Nobel Biocare AB · Oct 2009
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K091907 · Nobel Biocare AB · Oct 2009
NOBELPROCERA TI ABUTMENT
K091756 · Nobel Biocare AB · Sep 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069 · Nobel Biocare AB · May 2009
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
K090723 · Zimmer Dental, Inc. · Apr 2009