Home / 510(k) Clearances / K800919

510(k) K800919

ORAVIEW BY WATER PIK by Teledyne, Inc. — Product Code EAX

K800919 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "ORAVIEW BY WATER PIK". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Teledyne, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 21, 1980
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 Teledyne, Inc.

  • K871828 — TED MODEL 760 (February 4, 1988)
  • K863131 — PIK POCKET (IRRIGATING TIP) (August 26, 1986)
  • K862695 — FLUOR-ETCH GEL ETCHANT (July 31, 1986)
  • K854817 — INSTAPURE (February 28, 1986)
  • K840721 — PERIO PIK (April 25, 1984)
  • K810864 — WATER PIK ORAL HYGIENE CENTER (April 21, 1981)
  • K810805 — WATER PIK AUTOMATIC TOOTHBRUSH (April 14, 1981)
  • K801593 — LEBODY BY WATER PIK (August 20, 1980)
  • K800448 — WATER PIK TRAVELER, MODEL 79 (March 5, 1980)

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)
  • 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)

FDA data resources