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510(k) K841199

FIBERGLASS MOUTH MIRRORS by Henry Schein, Inc. — Product Code EAX

K841199 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "FIBERGLASS MOUTH MIRRORS". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
March 21, 1984
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 Henry Schein, Inc.

  • K041580 — IMAGERAYI (June 29, 2004)
  • K862384 — SCHEIN AP-1 AIR POLISHING UNIT (November 7, 1986)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

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)
  • 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