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510(k) K872098

CREMEEN ALVEOLAR BONE CALIPER by Bowen & Company, Inc. — Product Code EIL

K872098 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "CREMEEN ALVEOLAR BONE CALIPER". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1987
Date Received
June 1, 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 by Bowen & Company, Inc.

  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896538 — DISPOSABLE 45 DEGREE SHAVER (December 6, 1989)
  • K873766 — STERNAL POWER AWL (November 14, 1988)
  • K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE (June 8, 1987)
  • K870881 — LOOSE BODY GRASPERS (March 23, 1987)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)
  • K863150 — BOWEN CANNULA (September 5, 1986)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)

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)
  • K872215 — PERIO-TEST (July 10, 1987)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)

FDA data resources