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510(k) K812277

PRISMA-FIL COMPULES by Caulk Co., Div. Dentsply — Product Code EID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Restorative And Impression Material
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Caulk Co., Div. Dentsply

  • K782080 — VENEER SYSTEM, MOSTIQUE LAMINATE (January 26, 1979)

Other clearances for product code EID

  • K941431 — BONE GRAFT DELIVERY SYRINGES (July 12, 1994)
  • K913974 — ACCESS IMPRESSION BARREL (February 25, 1992)
  • K873153 — CAULK'S VPS CARTRIDGE SYSTEM (September 16, 1987)
  • K871937 — IMPRESSION SYRINGE (June 5, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812680 — G-C IMPRESSION SYRINGE (October 6, 1981)
  • K811582 — THE PLACER (July 28, 1981)
  • K781977 — APPLICATOR, LEE IMPRESSION (December 20, 1978)