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510(k) K821784

BEACH GINGIVAL RETRACTION INSTR. TYPE B by Pacific Dental Corp. — Product Code EIG

K821784 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "BEACH GINGIVAL RETRACTION INSTR. TYPE B". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code EIG (Retractor, All Types), 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
Retractor, All Types
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)
  • K821783 — BEACH SILICATE FILLING & LINING APPLIC. (July 6, 1982)
  • K821787 — BEACH SURGICAL PLIERS NON-HOOK (July 6, 1982)
  • K821790 — BEACH EXCAVATOR'S NO. 1 & NO. 2 (July 6, 1982)
  • K821786 — BEACH SCALERS (July 6, 1982)
  • K821789 — BEACH CURETTE NO. 2 AND NO. 3 T.G. (July 6, 1982)
  • K821780 — BEACH EXPLORER NO. 23T.G. (July 6, 1982)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)
  • K821778 — BEACH DRESSING PLIER (July 6, 1982)

Other clearances for product code EIG

  • K971284 — OPALDAM (June 3, 1997)
  • K854711 — FIBRELIGHT ILLUMINATING ORAL RETRACTORS (February 25, 1986)
  • K832366 — ZOLLER BURNED LIP CONFORMER (September 26, 1983)
  • K771973 — GINGITRACT (November 7, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)
  • K760657 — RACESTYPTINE CORD (September 27, 1976)

FDA data resources