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510(k) K842720

BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL by Penn-Med Technology, Inc. — Product Code EJL

K842720 is an FDA 510(k) premarket notification submitted by Penn-Med Technology, Inc. for the device "BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL". The FDA issued a decision of Substantially Equivalent on May 21, 1985. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Penn-Med Technology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Dental
Device Class
Class I
Regulation Number
872.3240
Review Panel
DE
Submission Type

Other clearances by Penn-Med Technology, Inc.

  • K843049 — CURING LIGHT (April 12, 1985)

Other clearances for product code EJL

  • K080687 — SMARTBURS (June 20, 2008)
  • K071352 — CERADRILL (June 29, 2007)
  • K061383 — BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (August 3, 2006)
  • K943273 — TRI HAWK BUR, FG BUR (August 1, 1994)
  • K926205 — MONOSTERYL (February 10, 1994)
  • K923883 — DENTAL OR SURGICAL BUR (July 27, 1993)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K920243 — SMART BURS TOTAL CARBIDES (March 25, 1992)
  • K911208 — TIN COATED DENTAL BURS (September 16, 1991)
  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)

FDA data resources