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510(k) K861150

EXEL DENTAL NEEDLE by Exel Intl. — Product Code DZM

K861150 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL DENTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
March 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Dental
Device Class
Class I
Regulation Number
872.4730
Review Panel
DE
Submission Type

Other clearances by Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895769 — EXEL HUBER NEEDLE (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)

Other clearances for product code DZM

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K920758 — JENKER NEEDLE STICK PROTECTOR (April 28, 1992)
  • K914562 — ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM (March 9, 1992)
  • K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE (November 7, 1991)
  • K910475 — DENTAL NEEDLE PROTECTIVE SYSTEM (September 13, 1991)
  • K910446 — STABIDENT LOCAL ANESTHESIA SYSTEM (June 3, 1991)
  • K896219 — SAFE-T-CAP NEEDLE COVER (January 22, 1990)
  • K894373 — NIPRO DENTAL NEEDLE (October 13, 1989)
  • K870921 — DENTAL NEEDLE (CARTRIDGE TYPE) (April 3, 1987)
  • K864970 — TERUMO DENTAL NEEDLES (March 10, 1987)

FDA data resources