Cleared Special

K052600 - ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)

K052600 is an FDA 510(k) clearance for ZIMMER DENTAL HEX-LOCK PREPARED ABUTMEN..., manufactured by Zimmer Dental, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 22-day FDA review.

K052600 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
22d
Days
Class 2
Risk

K052600 is an FDA 510(k) clearance for the ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED). 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 Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 13, 2005 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. 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.

FDA 510(k) Submission Details - K052600

510(k) Number K052600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2005
Decision Date October 13, 2005
Days to Decision 22 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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K052600.
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
K052648 · Implant Innovations, Inc. · Oct 2005
ZIRACE
K051501 · Acucera, Inc. · Oct 2005
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
K052070 · Atlantis Components, Inc. · Oct 2005
SPI EASY TEMPORARY CAP
K051527 · Thommen Medical AG · Jul 2005
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT
K051652 · Atlantis Components, Inc. · Jul 2005
RELIADENT DENTAL IMPLANT SYSTEM
K043428 · Bioinfera, Inc. · Jul 2005
K052600 · ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
Download PDF FDA Summary Zimmer Dental, Inc.