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510(k) K801079

KWIX-BITE X-RAY FILM HOLDER by Henry Schein, Inc. — Product Code EGZ

K801079 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "KWIX-BITE X-RAY FILM HOLDER". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
May 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Film, X-Ray
Device Class
Class I
Regulation Number
872.1905
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)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

Other clearances for product code EGZ

  • K913168 — SALIBAG (September 6, 1991)
  • K913160 — ID-TAB (September 6, 1991)
  • K890355 — DENTAL X-RAY BITE BLOCK (June 12, 1989)
  • K853451 — TROLL-BITE (January 21, 1986)
  • K852170 — EZX YELLOW, BLUE OR ORANGE (September 5, 1985)
  • K853005 — S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (August 13, 1985)
  • K813378 — UNI-BITE DENTAL X-RAY FILM HOLDER (January 29, 1982)

FDA data resources