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510(k) K823325

DENTAL INSTRUMENTS - SURGICAL FORCEPS by Miltex, Inc. — Product Code EMG

K823325 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "DENTAL INSTRUMENTS - SURGICAL FORCEPS". The FDA issued a decision of Substantially Equivalent on November 24, 1982. The device falls under product code EMG (Forceps, Tooth Extractor, 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
Forceps, Tooth Extractor, 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 EMG

  • K062130 — MEISINGER BENEX, MODEL BE001 (April 16, 2007)
  • K060691 — EASY X-TRAC SYSTEM (June 12, 2006)
  • K851708 — 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA (July 1, 1985)
  • K851712 — 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI (June 11, 1985)
  • K851709 — 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN (June 11, 1985)
  • K851711 — 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE (June 11, 1985)
  • K851105 — TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ (May 15, 1985)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K821781 — BEACH FORCEP NO. 150 AND NO. 151 (July 2, 1982)

FDA data resources