Cleared Traditional

K083886 - SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004

K083886 is an FDA 510(k) clearance for SIMPLER MINI IMPLANT, manufactured by Simpler One Stop. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K083886 · Simpler One Stop · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
84d
Days
Class 2
Risk

K083886 is an FDA 510(k) clearance for the SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Simpler One Stop (Vancouver, Bc, CA). The FDA issued a Cleared decision on March 23, 2009 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Simpler One Stop devices

FDA 510(k) Submission Details - K083886

510(k) Number K083886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date March 23, 2009
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 935
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083886.
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009
HG II FIXTURE SYSTEM
K090237 · Hiossen, Inc. · Apr 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K081419 · Institut Straumann AG · Feb 2009
NOBELACTIVE 8.5 MM & 18.0 MM
K083205 · Nobel Biocare AB · Feb 2009