Cleared Special

K072980 - NOBELPERFECT CONICAL CONNECTION HEXAGON...

K072980 is the FDA 510(k) clearance for NOBELPERFECT CONICAL CONNECTION HEXAGON... by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Special 510(k) pathway after a 58-day FDA review.

K072980 · Nobel Biocare AB · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
58d
Days
Class 2
Risk

K072980 is an FDA 510(k) clearance for the NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 58 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K072980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2007
Decision Date December 20, 2007
Days to Decision 58 days
Submission Type Special
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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072980.
MS SYSTEM (DENTURE)
K072959 · Osstem Implant Co., Ltd. · Feb 2008
MS SYSTEM (PROVISIONAL)
K072871 · Osstem Implant Co., Ltd. · Jan 2008
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
K070857 · Nobel Biocare AB · Dec 2007
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · BioHorizons Implant Systems, Inc. · Oct 2007
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
K072589 · Zimmer Dental, Inc. · Oct 2007