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510(k) K872215

PERIO-TEST by Dr. Bernard Loewenthal — Product Code EIL

K872215 is an FDA 510(k) premarket notification submitted by Dr. Bernard Loewenthal for the device "PERIO-TEST". The FDA issued a decision of Substantially Equivalent on July 10, 1987. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1987
Date Received
June 9, 1987
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 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)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)

FDA data resources