Cleared Traditional

K102769 - NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE

K102769 is an FDA 510(k) clearance for NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE, manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. The device is a Class 2 Dental device with product code OAT cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K102769 · Jjgc Industria E Comercio DE Materiais Dentarios S · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
152d
Days
Class 2
Risk

K102769 is an FDA 510(k) clearance for the NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S (San Diego, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 152 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 - K102769

510(k) Number K102769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date February 23, 2011
Days to Decision 152 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
24d slower than avg
Panel avg: 128d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAT Device Classification - Class 2, Special Controls

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
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 - OAT Implant, Endosseous, Orthodontic

All 51
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K102769.
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
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K110275 · Forestadent Bernhard Forster GmbH · Jun 2011
ORTHODONTIC SCREW
K103105 · Osstem Implant Co., Ltd. · Mar 2011
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · Synthes (Usa) · Dec 2010
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
K100633 · D B Orthodontics, Ltd. · Apr 2010
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
K091390 · Hdc S.R.L. · Jul 2009