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510(k) K822793

PIO ROOT CANAL INDICATOR by National Patent Development Corp. — Product Code EIL

K822793 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "PIO ROOT CANAL INDICATOR". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), 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
October 22, 1982
Date Received
September 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Depth, Instrument, Dental
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)
  • 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)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (July 21, 1980)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (January 16, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)

Other clearances for product code EIL

  • K911643 — ABIODENT PERIOTEMP(R) SYSTEM (July 9, 1991)
  • K890493 — FLORIDA PROBE PERIODONTAL PROBE (March 13, 1989)
  • K885075 — ABIOMED PERIOTEMP(TM) PROBE (February 13, 1989)
  • K884813 — MODEL 200A ELECTRONIC FORCE-SENSING PROBE (January 5, 1989)
  • K880209 — PERIODONTAL PROBE - AUTOPROBE (April 27, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K872215 — PERIO-TEST (July 10, 1987)

FDA data resources