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510(k) K833304

HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST by Smith & Nephew, Mpl Division — Product Code DZM

K833304 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
September 23, 1983
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 Smith & Nephew, Mpl Division

  • K843314 — MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (September 27, 1984)
  • K841280 — SOLOPAK BRAND FILTER NEEDLE W/5 MICRO (May 21, 1984)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830524 — HENKE JECT PRESSURE SYRINGE (March 24, 1983)
  • K830242 — MICRO 2 HYPODERMIC NEEDLES (February 15, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

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