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510(k) K821782

BEACH ANESTHETIC SYRINGE CARTR. TYPE by Pacific Dental Corp. — Product Code EJI

K821782 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "BEACH ANESTHETIC SYRINGE CARTR. TYPE". The FDA issued a decision of Substantially Equivalent on July 20, 1982. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
June 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

Other clearances by Pacific Dental Corp.

  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 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)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K821783 — BEACH SILICATE FILLING & LINING APPLIC. (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 EJI

  • K171254 — LeEject 2 Dental Syringe and Needle System (November 16, 2017)
  • K142414 — Miltex N-Tralig Intraligamentary Syringe (October 30, 2014)
  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K082249 — MORPHEUS (December 31, 2009)
  • K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (December 11, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)

FDA data resources