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510(k) K911643

ABIODENT PERIOTEMP(R) SYSTEM by Abiomed, Inc. — Product Code EIL

K911643 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "ABIODENT PERIOTEMP(R) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 1991. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Abiomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
April 12, 1991
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 Abiomed, Inc.

  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K241708 — Abiomed 14Fr Low Profile Introducer Kit (August 6, 2024)
  • K221294 — preCARDIA Occlusion System (June 30, 2023)
  • K223161 — OXY-1 System (February 23, 2023)
  • K222113 — Abiomed 14Fr Low Profile Introducer Set (October 13, 2022)
  • K202330 — Impella XR Sheath Set (December 7, 2020)
  • K200109 — OXY-1 System (October 23, 2020)
  • K201116 — Abiomed 23 Fr Sheath (June 15, 2020)
  • K192769 — Impella CP Introducer (November 18, 2019)
  • K112892 — IMPELLA 2.5 PLUS CATHETER (September 6, 2012)

Other clearances for product code EIL

  • 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)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)

FDA data resources