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510(k) K870921

DENTAL NEEDLE (CARTRIDGE TYPE) by Churchill Corp. — Product Code DZM

K870921 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "DENTAL NEEDLE (CARTRIDGE TYPE)". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Churchill Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1987
Date Received
March 5, 1987
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 Churchill Corp.

  • K880051 — ENTERAL BAG/SET (April 14, 1988)
  • K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS (April 14, 1988)
  • K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS (April 14, 1988)
  • K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET (April 13, 1988)
  • K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA (October 15, 1987)
  • K872585 — CHURCHILL-CATH (October 15, 1987)
  • K872124 — CHURCHILL ALBUMIN IV ADMINISTRATION SET (October 13, 1987)
  • K872123 — CHURCHILL TPN ADMINISTRATION SET (October 9, 1987)
  • K872043 — CHURCHILL INTER-CARDIAC SUCKER (September 30, 1987)
  • K871084 — NITROGLYCERINE PUMP SET (July 16, 1987)

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

FDA data resources