Home / 510(k) Clearances / K823326

510(k) K823326

DENTAL INSTRUMENTS - CUTTING INSTRUMENT by Miltex, Inc. — Product Code ELA

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
Instrument, Hand, Calculus Removal
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 ELA

  • K952363 — OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (August 15, 1995)
  • K854168 — TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (March 13, 1986)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)