Home / 510(k) Clearances / K800574

510(k) K800574

VACUDENT LUMIX 65 by Vacudent Sales Corp. — Product Code EHP

K800574 is an FDA 510(k) premarket notification submitted by Vacudent Sales Corp. for the device "VACUDENT LUMIX 65". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285. Vacudent Sales Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
March 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clasp, Preformed
Device Class
Class I
Regulation Number
872.3285
Review Panel
DE
Submission Type

Other clearances by Vacudent Sales Corp.

  • K800575 — VACUDENT LUMIX 70 (May 20, 1980)
  • K800520 — DENTAL STOOLS, #'S P2212, P1121, ETC. (March 18, 1980)
  • K781882 — MODULAT DENTAL SYSTEMS (December 28, 1978)

Other clearances for product code EHP

  • K022032 — ACETAL (August 29, 2002)
  • K983558 — ACETAL DENTAL/PREFORMED CLASP (January 7, 1999)
  • K974622 — DENTAL D (February 10, 1998)
  • K955946 — ACETAL DENTAL/PREFORMED CLASP (December 11, 1995)
  • K954971 — ACETAL DENTAL/PREFORMED CLASP (December 11, 1995)
  • K854765 — INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH (June 13, 1986)
  • K800575 — VACUDENT LUMIX 70 (May 20, 1980)

FDA data resources