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510(k) K091390

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

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.

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  • 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)

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