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510(k) K821777

BEACH MOUTH MIRROR by Pacific Dental Corp. — Product Code EAX

K821777 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "BEACH MOUTH MIRROR". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1982
Date Received
June 17, 1982
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 Pacific Dental Corp.

  • K821782 — BEACH ANESTHETIC SYRINGE CARTR. TYPE (July 20, 1982)
  • K821780 — BEACH EXPLORER NO. 23T.G. (July 6, 1982)
  • K821787 — BEACH SURGICAL PLIERS NON-HOOK (July 6, 1982)
  • K821786 — BEACH SCALERS (July 6, 1982)
  • K821789 — BEACH CURETTE NO. 2 AND NO. 3 T.G. (July 6, 1982)
  • K821783 — BEACH SILICATE FILLING & LINING APPLIC. (July 6, 1982)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K821790 — BEACH EXCAVATOR'S NO. 1 & NO. 2 (July 6, 1982)
  • K821778 — BEACH DRESSING PLIER (July 6, 1982)

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