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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 Oct 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 33 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 22, 1982
Date Received
Sep 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
510(k) Exempt

Other clearances by National Patent Development Corp.

  • K843974 — VARIABLE TEMPERATURE CAUTERY DEVICE (Feb 26, 1985)
  • K832699 — HYDRON WOUND DRESSING FAST SEAT KIT (Apr 27, 1984)
  • K820028 — ZEON COMPOSITE RESIN LIGHT CURE SYS (Mar 11, 1982)
  • K820006 — ZEON COMPOSITE RESIN SYSTEM (Jan 22, 1982)
  • K811446 — HYDRON WOUND DRESSING KIT (Jun 12, 1981)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (Jul 21, 1980)
  • K801482 — HYDRON ROOT CANAL FILLING MATERIAL (Jul 21, 1980)
  • K801483 — MARK IV SYRINGE (Jul 21, 1980)
  • K792136 — HYPO-ALLERGENIC PLASTIC TAPE (Jan 16, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (Dec 20, 1979)

Other clearances for product code EIL

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

FDA data resources