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510(k) K801686

SPACELINE THREE WAY SYRINGE by Pacific Dental Corp. — Product Code ECB

K801686 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "SPACELINE THREE WAY SYRINGE". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), 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
August 4, 1980
Date Received
July 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
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)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)
  • K821780 — BEACH EXPLORER NO. 23T.G. (July 6, 1982)

Other clearances for product code ECB

  • K942519 — UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (August 23, 1994)
  • K931772 — SURETIP SYRINGE TIP COVER (March 7, 1994)
  • K931137 — DENTAL SYRINGE TIP (November 29, 1993)
  • K923876 — RISKONTROL SINGLE USE (April 5, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 1992)
  • K920499 — SANI-TIP (May 3, 1992)
  • K911756 — POSTERIOR NASAL EPISTAXIS INSTRUMENTS (October 24, 1991)
  • K890290 — BRACE (ORAFIX SPECIAL) (March 29, 1989)
  • K863024 — SERINGA TRIPLICE S.L. (September 25, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

FDA data resources