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510(k) K894373

NIPRO DENTAL NEEDLE by Pharma-Plast USA, Inc. — Product Code DZM

K894373 is an FDA 510(k) premarket notification submitted by Pharma-Plast USA, Inc. for the device "NIPRO DENTAL NEEDLE". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Pharma-Plast USA, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
July 17, 1989
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 Pharma-Plast USA, Inc.

  • K894371 — NIPRO SAFELET CATH (October 25, 1989)
  • K894374 — BLOOD DRAWING NEEDLE (September 28, 1989)
  • K894372 — NIPRO NEEDLE HOLDER (September 28, 1989)
  • K884978 — PHARMA-PLAST INSULIN INFUSION SET (June 21, 1989)
  • K871263 — MULTIPLE PHARMA-PLAST TRACHEAL TUBE (June 15, 1987)
  • K852443 — PHARMA-PLAST CLINIPAK (October 16, 1985)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)
  • K852442 — PHARMA-PLAST NEEDLE (September 20, 1985)

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)
  • K870921 — DENTAL NEEDLE (CARTRIDGE TYPE) (April 3, 1987)
  • K864970 — TERUMO DENTAL NEEDLES (March 10, 1987)
  • K861150 — EXEL DENTAL NEEDLE (April 11, 1986)

FDA data resources