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510(k) K833039

HANDY IIM by Shofu Dental Corp. — Product Code EJP

K833039 is an FDA 510(k) premarket notification submitted by Shofu Dental Corp. for the device "HANDY IIM". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150. Shofu Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
September 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Articulators
Device Class
Class I
Regulation Number
872.3150
Review Panel
DE
Submission Type

Other clearances by Shofu Dental Corp.

  • K111855 — HY-BOND RESIGLASS (November 17, 2011)
  • K110252 — BEAUTIBOND MULTI PR PLUS (May 13, 2011)
  • K110235 — BEAUTIBOND MULTI (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 EJP

  • K926190 — ALRAND INC. (DENTAL HAND INSTRUMENTS) (January 18, 1994)
  • K896131 — GNATHOMAT ARTICULATOR (December 4, 1989)
  • K892373 — DENTAL PLASTIC BITE FORK (June 12, 1989)
  • K884418 — PREMIER DIE-TRAK ARTICULATOR (November 14, 1988)
  • K872943 — DISPOSABLE ARTICULATOR (August 11, 1987)
  • K863009 — GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (September 25, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K811075 — BALANCE ARTICULATOR (May 13, 1981)
  • K810971 — THE GNATOMET (May 5, 1981)
  • K801342 — DISPOSABLE ARTICULATOR (July 8, 1980)

FDA data resources