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510(k) K891612

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. by Implant Innovations International, Inc. — Product Code EFD

K891612 is an FDA 510(k) premarket notification submitted by Implant Innovations International, Inc. for the device "DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Implant Innovations International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amalgamator, Dental, Ac-Powered
Device Class
Class I
Regulation Number
872.3100
Review Panel
DE
Submission Type

Other clearances by Implant Innovations International, Inc.

  • K935544 — 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION (March 13, 1995)
  • K932123 — IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM (May 27, 1994)
  • K911655 — IMPLARETTE (October 21, 1991)
  • K905303 — ABUTMENT GLO (June 10, 1991)
  • K911701 — G-FLOSS & G-FLOSS II (May 15, 1991)
  • K891613 — OVERDENTURE ATTACHMENT (October 10, 1989)
  • K891617 — INSERTION TOOLS (May 1, 1989)
  • K891618 — TITANIUM FORCEPS (April 17, 1989)
  • K891615 — SURGICAL DRILLS (April 17, 1989)
  • K874590 — INNOVATIVE IMPLANTS AND COVER SCREWS (May 11, 1988)

Other clearances for product code EFD

  • K991913 — PENTAMIX 2 (July 26, 1999)
  • K923974 — SILIMAT PLUS (October 6, 1992)
  • K922203 — IPT CAPSULE MIXER (June 3, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K914340 — DUOMAT 3 AMALGAMATOR (November 13, 1991)
  • K914341 — MIXOMAT AMALGAMATOR (November 13, 1991)
  • K914339 — DENTOMAT 3 AMALGAMATORS (November 7, 1991)
  • K910632 — ACCU-MIX AMALGAMATOR (March 15, 1991)
  • K901909 — SILAMAT (AMALGAMATOR) (June 22, 1990)
  • K891064 — ESPE CAPMIX (May 30, 1989)

FDA data resources