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510(k) K830777

ELECTRIC MOUTH MIRROR by Almore Intl., Inc. — Product Code EAX

K830777 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "ELECTRIC MOUTH MIRROR". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 11, 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 Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

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)
  • K833429 — PERI MIRROR/SALIVA EJECTOR (December 22, 1983)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)

FDA data resources