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510(k) K802987

JOTA DIAMOND DENTAL BURS by Swiss American Metal Craft Corp. — Product Code DZP

K802987 is an FDA 510(k) premarket notification submitted by Swiss American Metal Craft Corp. for the device "JOTA DIAMOND DENTAL BURS". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Swiss American Metal Craft Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1980
Date Received
November 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Diamond, Dental
Device Class
Class I
Regulation Number
872.4535
Review Panel
DE
Submission Type

Other clearances by Swiss American Metal Craft Corp.

  • K802984 — MEISINGER DIAMOND DENTAL BURS (December 30, 1980)
  • K802988 — JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS (December 30, 1980)
  • K802989 — MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. (December 30, 1980)

Other clearances for product code DZP

  • K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED (April 20, 2012)
  • K943841 — SOPHOS DENTAL DIAMOND (September 16, 1994)
  • K940908 — DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (August 29, 1994)
  • K934981 — DENTAL DRILL (February 3, 1994)
  • K923757 — DENTAL DIAMOND DRILLS (March 16, 1993)
  • K913651 — MANI DIA-BURS (January 14, 1992)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K901262 — F.G. LASER (DENTAL BUR) (July 9, 1990)
  • K900089 — FG DIAMOND BURRS (April 3, 1990)
  • K893844 — 3D DENTAL DIAMOND ROTARY INSTRUMENTS (August 11, 1989)

FDA data resources