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510(k) K760987

DIAMOND STONES by Adp Intl., Inc. — Product Code DZP

K760987 is an FDA 510(k) premarket notification submitted by Adp Intl., Inc. for the device "DIAMOND STONES". The FDA issued a decision of Substantially Equivalent on November 15, 1976. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Adp Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1976
Date Received
October 21, 1976
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 Adp Intl., Inc.

  • K760980 — DENTAL ALLOY (November 15, 1976)
  • K760986 — CARBIDE DENTAL BURS (November 15, 1976)
  • K760988 — DENTAL HANDPIECES (November 15, 1976)
  • K760978 — ZINC CEMENT (November 15, 1976)
  • K760979 — COMPOSITE MATERIAL (November 15, 1976)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)
  • K760981 — ALGINATE IMPRESSION MATERIAL (November 15, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)
  • K760982 — DENTAL VARNISH (November 15, 1976)
  • K760984 — ORTHODONTIC INSTRUMENTS (November 15, 1976)

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