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510(k) K935906

RANIR PLAX RX by Ranir/Dcp Corp. — Product Code EAX

K935906 is an FDA 510(k) premarket notification submitted by Ranir/Dcp Corp. for the device "RANIR PLAX RX". The FDA issued a decision of Substantially Equivalent on September 2, 1994. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Ranir/Dcp Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
December 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Mouth
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Ranir/Dcp Corp.

  • K955530 — RANIR HI-TECHNOLOGY DENTAL FLOSS (December 28, 1995)
  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K942689 — RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K935522 — RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE (January 26, 1994)
  • K924739 — THE DENTIST'S TOOTH POLISHER (November 24, 1992)

Other clearances for product code EAX

  • K946073 — ORALVUE DENTAL MIRROR (February 16, 1995)
  • K941574 — RETRO MIRROR (May 18, 1994)
  • K935687 — NIL (February 3, 1994)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K833310 — FOGCUTTER DENTAL MOUTH MIRROR (May 7, 1984)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K833429 — PERI MIRROR/SALIVA EJECTOR (December 22, 1983)
  • K830777 — ELECTRIC MOUTH MIRROR (April 6, 1983)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)

FDA data resources