Cleared Traditional

K053373 - ATLANTIS ABUTMENT FOR ZIMMER INTERFACE

K053373 is an FDA 510(k) clearance for ATLANTIS ABUTMENT FOR ZIMMER INTERFACE, manufactured by Atlantis Components, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K053373 · Atlantis Components, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
207d
Days
Class 2
Risk

K053373 is an FDA 510(k) clearance for the ATLANTIS ABUTMENT FOR ZIMMER INTERFACE. 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 Atlantis Components, Inc. (Skokie, US). The FDA issued a Cleared decision on June 30, 2006 after a review of 207 days - an extended review 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: 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 Atlantis Components, Inc. devices

FDA 510(k) Submission Details - K053373

510(k) Number K053373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date June 30, 2006
Days to Decision 207 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
80d slower than avg
Panel avg: 127d · This submission: 207d
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 558
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K053373.
SPI ART ABUTMENTS
K061807 · Thommen Medical AG · Jul 2006
IMPLANTIUM PROSTHETICS
K052957 · Dentium Co., Ltd. · Jul 2006
PREFORMANCE POSTS AND TEMPORARY CYLINDERS
K061969 · Implant Innovations, Inc. · Jul 2006
ZIMMER CONTOUR RESTORATIVE SYSTEM
K061043 · Zimmer Dental, Inc. · Jun 2006
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
K060880 · Zimmer Dental, Inc. · May 2006
PROVIDE TEMPORARY CYLINDER
K061177 · Implant Innovations, Inc. · May 2006