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510(k) K833310

FOGCUTTER DENTAL MOUTH MIRROR by Hti, Inc. — Product Code EAX

K833310 is an FDA 510(k) premarket notification submitted by Hti, Inc. for the device "FOGCUTTER DENTAL MOUTH MIRROR". The FDA issued a decision of Substantially Equivalent on May 7, 1984. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1984
Date Received
September 26, 1983
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 for product code EAX

  • K946073 — ORALVUE DENTAL MIRROR (February 16, 1995)
  • K935906 — RANIR PLAX RX (September 2, 1994)
  • 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)
  • 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