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510(k) K914562

ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM by Aseptic Dental Technologies, Inc. — Product Code DZM

K914562 is an FDA 510(k) premarket notification submitted by Aseptic Dental Technologies, Inc. for the device "ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 9, 1992. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1992
Date Received
October 15, 1991
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 for product code DZM

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K920758 — JENKER NEEDLE STICK PROTECTOR (April 28, 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)
  • K861150 — EXEL DENTAL NEEDLE (April 11, 1986)

FDA data resources