Cleared Special

K091390 - HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2

K091390 is an FDA 510(k) clearance for HDC STERILE SELF LIGATING SPIDER SCREW, manufactured by Hdc S.R.L.. The device is a Class 2 Dental device with product code OAT cleared through the Special 510(k) pathway after a 80-day FDA review.

K091390 · Hdc S.R.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
80d
Days
Class 2
Risk

K091390 is an FDA 510(k) clearance for the HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Hdc S.R.L. (Imola, Bologna, IT). The FDA issued a Cleared decision on July 30, 2009 after a review of 80 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091390

510(k) Number K091390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date July 30, 2009
Days to Decision 80 days
Submission Type Special
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
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 K091390.
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
K102769 · Jjgc Industria E Comercio DE Materiais Dentarios S · Feb 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
SYNTEC ORTHODONTIC MINI SCREW
K090476 · Syntec Scientific Corp. · Jun 2009
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
K081393 · G & H Wire Co. · Aug 2008
LEONE ORTHODONTIC MINI IMPLANT
K071490 · Leone S.P.A. · Feb 2008
K091390 · HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
Download PDF FDA Summary Hdc S.R.L.