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510(k) K854347

HYBRID POINTS by Shofu Dental Corp. — Product Code DZP

K854347 is an FDA 510(k) premarket notification submitted by Shofu Dental Corp. for the device "HYBRID POINTS". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Shofu Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
October 29, 1985
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 Shofu Dental Corp.

  • K111855 — HY-BOND RESIGLASS (November 17, 2011)
  • K110235 — BEAUTIBOND MULTI (May 13, 2011)
  • K110252 — BEAUTIBOND MULTI PR PLUS (May 13, 2011)
  • K101621 — LITE ART (August 23, 2010)
  • K101603 — BEAUTIFIL FLOW PLUS (August 23, 2010)
  • K093559 — VINTAGE MP (March 3, 2010)
  • K082744 — BEAUTIBOND (December 11, 2008)
  • K080834 — VINTAGE ART (June 11, 2008)
  • K080517 — RESICEM (June 11, 2008)
  • K080068 — BEAUTIFIL OPAQUER (February 28, 2008)

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