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510(k) K823320

DENTAL INSTRUMENTS - BONE CHISELS by Miltex, Inc. — Product Code EML

K823320 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "DENTAL INSTRUMENTS - BONE CHISELS". The FDA issued a decision of Substantially Equivalent on November 24, 1982. The device falls under product code EML (Chisel, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Miltex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1982
Date Received
November 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel, Bone, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Miltex, Inc.

  • K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES (August 2, 2010)
  • K092855 — MILTEX MEMBRANE TACK KIT (December 29, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K072563 — MILTEX RIGID CONTAINER SYSTEMS (February 12, 2008)
  • K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) (December 12, 2006)
  • K052018 — MILTEX LIGATING CLIP (November 4, 2005)
  • K050570 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM (July 25, 2005)
  • K043013 — MILTEX LAPAROSCOPIC INSTRUMENTS (March 4, 2005)
  • K013888 — FIXATION (STEINMANN) PINS (May 1, 2002)
  • K954185 — RE-BAG MULTI-USE POUCH, LARGE & SMALL (December 4, 1995)

Other clearances for product code EML

  • K851715 — 830/4 TO 848/7 VARIOUS TYPES CHISELS (June 11, 1985)

FDA data resources