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510(k) K982229

BI-DENT by Valley Forge Scientific Corp. — Product Code EKZ

K982229 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "BI-DENT". The FDA issued a decision of Substantially Equivalent on August 13, 1998. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1998
Date Received
May 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

Other clearances by Valley Forge Scientific Corp.

  • K050364 — MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM (March 9, 2005)
  • K042604 — VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL (October 22, 2004)
  • K032601 — STRYKER INTERVENTIONAL PAIN RF GENERATOR (April 1, 2004)
  • K033499 — MALIS IRRIGATION MODULE 1000 (November 28, 2003)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971986 — VALLEY FORGE BIPOLAR LOOP (August 26, 1997)
  • K964143 — MINI-SYMM BIPOLAR COAGULATOR (January 9, 1997)
  • K955764 — VALLEY FORGE BIPLOAR LOOP (March 1, 1996)
  • K955346 — VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM (December 8, 1995)
  • K951985 — PRECISION BIPOLAR COAGULATOR (May 23, 1995)

Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources