Cleared Traditional

K053629 - ANCHOR PLUS/NEO ANCHOR PLUS

K053629 is an FDA 510(k) clearance for ANCHOR PLUS/NEO ANCHOR PLUS, manufactured by Kj Meditech. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K053629 · Kj Meditech · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
153d
Days
Class 2
Risk

K053629 is an FDA 510(k) clearance for the ANCHOR PLUS/NEO ANCHOR PLUS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Kj Meditech (Flintville, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 153 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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.

FDA 510(k) Submission Details - K053629

510(k) Number K053629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2005
Decision Date May 31, 2006
Days to Decision 153 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
25d slower than avg
Panel avg: 128d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1542
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053629.
SPEEDY ORTHODONTIC SCREW
K060500 · Dentium Co., Ltd. · Jun 2006
IMPLANTIUM II
K060501 · Dentium Co., Ltd. · Jun 2006
MYTIS ARROW XXXX
K052254 · Brainbase Corporation · Jun 2006
ABSOANCHOR MICROIMPLANT
K060126 · Dentos, Inc. · May 2006
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K060957 · Blue Sky Bio, LLC · May 2006
SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
K060376 · Simpler Implant, Inc. · Apr 2006
K053629 · ANCHOR PLUS/NEO ANCHOR PLUS
Download PDF FDA Summary Kj Meditech