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510(k) K820568

MUSCLE DYSFUNCTION MONITOR by A Company, Inc. — Product Code DZM

K820568 is an FDA 510(k) premarket notification submitted by A Company, Inc. for the device "MUSCLE DYSFUNCTION MONITOR". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. A Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
March 2, 1982
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 A Company, Inc.

  • K897195 — A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (May 31, 1990)
  • K852596 — A-COMPANY ELASTIC LIGATURE RINGS (July 31, 1985)
  • K852597 — A-COMPANY ELASTIC ROTATION WEDGES (July 31, 1985)
  • K852599 — A-COMPANY ELASTOMERIC TUBING (July 31, 1985)
  • K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSER (July 31, 1985)
  • K852598 — A-COMPANY SEPARATING ELASTICS (July 31, 1985)
  • K852800 — A-COMPANY SELF-LIGATING APPLIANCE (July 31, 1985)
  • K852670 — A-COMPANY ESPREE SAFETY HEADGEAR (July 31, 1985)
  • K851878 — A COMPANY BRASS SEPARATING RINGS (June 5, 1985)
  • K851454 — A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (April 29, 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)
  • 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