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510(k) K893844

3D DENTAL DIAMOND ROTARY INSTRUMENTS by Lustgarten Multi-Tech International, Inc. — Product Code DZP

K893844 is an FDA 510(k) premarket notification submitted by Lustgarten Multi-Tech International, Inc. for the device "3D DENTAL DIAMOND ROTARY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 11, 1989. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Lustgarten Multi-Tech International, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1989
Date Received
May 25, 1989
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 Lustgarten Multi-Tech International, Inc.

  • K895085 — WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT (April 2, 1990)
  • K874458 — PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER (March 18, 1988)

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)
  • K885233 — NOVA DIAMOND (February 13, 1989)

FDA data resources