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510(k) K970715

SYSTEM B HEAT SOURCE by Sybron Dental Specialties, Inc. — Product Code EAT

K970715 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties, Inc. for the device "SYSTEM B HEAT SOURCE". The FDA issued a decision of Substantially Equivalent on April 7, 1997. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Sybron Dental Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1997
Date Received
February 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
Review Panel
DE
Submission Type

Other clearances by Sybron Dental Specialties, Inc.

  • K182826 — Ormco Spark Aligner System (October 11, 2018)
  • K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System (April 21, 2017)
  • K160097 — Image Fast Set, Image Regular Set (August 5, 2016)
  • K153067 — Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (July 27, 2016)
  • K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT (May 6, 2016)
  • K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (April 14, 2016)
  • K151526 — Zone, ZoneFree, Zone A1 (September 10, 2015)
  • K151332 — Nexus Universal, Nexus Universal Chroma (August 17, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)
  • K950238 — GENTAL PULSE (May 9, 1995)

FDA data resources