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510(k) K863998

COLTENE JET-MIXER by Coltene, Inc. — Product Code EID

K863998 is an FDA 510(k) premarket notification submitted by Coltene, Inc. for the device "COLTENE JET-MIXER". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Coltene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
October 14, 1986
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 Coltene, Inc.

  • K041098 — COOL TEMP NATURAL (May 13, 2004)
  • K022224 — COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM (September 18, 2002)
  • K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL (August 28, 1990)
  • K882800 — COLTENE PRESIDENT JET REGULAR BODY (September 23, 1988)
  • K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM (October 27, 1987)
  • K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM (February 27, 1987)
  • K870047 — COLTENE RAPID (January 29, 1987)
  • K850036 — COLTENE PRECISE (February 8, 1985)
  • K840297 — COLTENE ORALLOY MAGICAPS (March 16, 1984)
  • K811667 — COLTENE PRESSURE SPOT INDICATOR (July 15, 1981)

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)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812680 — G-C IMPRESSION SYRINGE (October 6, 1981)
  • K812277 — PRISMA-FIL COMPULES (September 8, 1981)
  • K811582 — THE PLACER (July 28, 1981)
  • K781977 — APPLICATOR, LEE IMPRESSION (December 20, 1978)

FDA data resources