Cleared Traditional

K121707 - LEW MDI O-BALL COLLARED IMPLANT

K121707 is an FDA 510(k) clearance for LEW MDI O-BALL COLLARED IMPLANT, manufactured by Park Dental Research Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K121707 · Park Dental Research Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
105d
Days
Class 2
Risk

K121707 is an FDA 510(k) clearance for the LEW MDI O-BALL COLLARED IMPLANT,. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Park Dental Research Corp. (Ardmore, US). The FDA issued a Cleared decision on September 24, 2012 after a review of 105 days - within the typical 510(k) review window.

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.

View all Park Dental Research Corp. devices

FDA 510(k) Submission Details - K121707

510(k) Number K121707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2012
Decision Date September 24, 2012
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K121707.
TS FIXTURE SYSTEM
K121995 · Osstem Implant Co., Ltd. · Nov 2012
MS SA IMPLANT SYSTEM
K122171 · Osstem Implant Co., Ltd. · Nov 2012
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM
K122231 · Megagen Implant Co., Ltd. · Oct 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · BioHorizons Implant Systems, Inc. · Sep 2012
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · Zimmer Dental, Inc. · Aug 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012