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510(k) K770967

SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE by National Patent Development Corp. — Product Code EIC

K770967 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE". The FDA issued a decision of Substantially Equivalent on June 20, 1977. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1977
Date Received
May 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by National Patent Development Corp.

  • K843974 — VARIABLE TEMPERATURE CAUTERY DEVICE (February 26, 1985)
  • K832699 — HYDRON WOUND DRESSING FAST SEAT KIT (April 27, 1984)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)
  • K820028 — ZEON COMPOSITE RESIN LIGHT CURE SYS (March 11, 1982)
  • K820006 — ZEON COMPOSITE RESIN SYSTEM (January 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (June 12, 1981)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (January 16, 1980)

Other clearances for product code EIC

  • K972234 — RCT GEL ROOT CANAL THERAPY GEL (June 30, 1997)
  • K864307 — MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (November 18, 1986)
  • K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (June 26, 1986)
  • K851944 — MAX-I-PROBE HANDPIECE (July 1, 1985)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K811889 — R & S SERIES FITTING TOOLS (July 24, 1981)
  • K811594 — WATER PISTOL (July 15, 1981)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K792578 — EPIC CANNULA (January 4, 1980)

FDA data resources