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510(k) K813378

UNI-BITE DENTAL X-RAY FILM HOLDER by Rinn Corp. — Product Code EGZ

K813378 is an FDA 510(k) premarket notification submitted by Rinn Corp. for the device "UNI-BITE DENTAL X-RAY FILM HOLDER". The FDA issued a decision of Substantially Equivalent on January 29, 1982. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905. Rinn Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
December 1, 1981
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 Rinn Corp.

  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K913885 — RINN E-Z CAPPER (December 13, 1991)
  • K828605 — BEAM LIMITING DEVICE (January 3, 1983)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 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)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)

FDA data resources