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510(k) K880209

PERIODONTAL PROBE - AUTOPROBE by Dentsply Intl. — Product Code EIL

K880209 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "PERIODONTAL PROBE - AUTOPROBE". The FDA issued a decision of Substantially Equivalent on April 27, 1988. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1988
Date Received
January 15, 1988
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 Dentsply Intl.

  • K140347 — ANKYLOS C/X IMPLANT SYSTEM (August 20, 2014)
  • K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (July 23, 2013)
  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (February 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (February 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (March 27, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)

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)
  • 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