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510(k) K913573

SAFETY PLUS DENTAL INJECTION NEEDLE by Specialites Septodont — Product Code DZM

K913573 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "SAFETY PLUS DENTAL INJECTION NEEDLE". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Specialites Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
August 12, 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 by Specialites Septodont

  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K010415 — ISODAN (July 23, 2001)
  • K982773 — QUICKSET LIQUID AND POWDER (November 3, 1998)
  • K982671 — SECURALLOY (October 19, 1998)
  • K980633 — ENDOSOLV E (May 1, 1998)
  • K920692 — SEPTOCALCINE ULTRA (April 21, 1992)
  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
  • K915466 — SEPTOPACK TEMPORARY FILLING (February 3, 1992)
  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)
  • K913574 — SEPTOCAL CAVITY LINER (September 30, 1991)

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)
  • 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