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510(k) K833429

PERI MIRROR/SALIVA EJECTOR by Dentec, Inc. — Product Code EAX

K833429 is an FDA 510(k) premarket notification submitted by Dentec, Inc. for the device "PERI MIRROR/SALIVA EJECTOR". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Dentec, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
October 5, 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 by Dentec, Inc.

  • K894930 — DENTEC 4000 (March 27, 1990)
  • K864376 — FIBERBOND (April 7, 1987)

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)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)
  • K833310 — FOGCUTTER DENTAL MOUTH MIRROR (May 7, 1984)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K830777 — ELECTRIC MOUTH MIRROR (April 6, 1983)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)

FDA data resources