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510(k) K091390

HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 by Hdc S.R.L. — Product Code OAT

K091390 is an FDA 510(k) premarket notification submitted by Hdc S.R.L. for the device "HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2". The FDA issued a decision of Substantially Equivalent on July 30, 2009. The device falls under product code OAT (Implant, Endosseous, Orthodontic), a Class II device regulated under 21 CFR 872.3640. Hdc S.R.L. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
May 11, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Orthodontic
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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.

Other clearances by Hdc S.R.L.

  • K071875 — V-CATH POLY PICC (November 5, 2007)
  • K071851 — HDC STERILE SPIDER SCREW (October 18, 2007)
  • K052471 — HDC SPIDER SCREW (December 23, 2005)
  • K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE (March 2, 2004)
  • K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 2004)
  • K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 2003)
  • K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-1 (September 9, 2003)
  • K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390- (September 20, 2002)
  • K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (March 15, 2001)
  • K994059 — CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (October 13, 2000)

Other clearances for product code OAT

  • K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck (May 19, 2026)
  • K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) (June 19, 2025)
  • K231502 — Mini Screws (September 4, 2024)
  • K231913 — T-FIT (February 8, 2024)
  • K222245 — ACR Screw System (August 21, 2023)
  • K202163 — Mico One Orthodontic Screw (October 7, 2022)
  • K202691 — Ortholock Anchorage Devices (April 28, 2022)
  • K210559 — ATOZ Mini-Screw (December 19, 2021)
  • K211992 — Ortho MI System (October 15, 2021)
  • K202790 — Syntec Orthodontic Mini Screw Extended System (September 17, 2021)

FDA data resources