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510(k) K834055

VANADIUM EXCAVATORS SIZES 0-6 by Henry Schein, Inc. — Product Code EKC

K834055 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "VANADIUM EXCAVATORS SIZES 0-6". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code EKC (Excavator, Dental, Operative), a Class I device regulated under 21 CFR 872.4565. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
November 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Excavator, Dental, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Henry Schein, Inc.

  • K041580 — IMAGERAYI (June 29, 2004)
  • K862384 — SCHEIN AP-1 AIR POLISHING UNIT (November 7, 1986)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

Other clearances for product code EKC

  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)

FDA data resources