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510(k) K895986

PRECISION DENTAL ATTACHMENTS by Implant Support Systems, Inc. — Product Code EGG

K895986 is an FDA 510(k) premarket notification submitted by Implant Support Systems, Inc. for the device "PRECISION DENTAL ATTACHMENTS". The FDA issued a decision of Substantially Equivalent on October 18, 1989. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Implant Support Systems, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type

Other clearances by Implant Support Systems, Inc.

  • K933532 — SELF TAPPING DENTAL IMPLANT SYSTEM (September 21, 1994)
  • K924589 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (June 22, 1994)
  • K925312 — HAND INSTRUMENT CALCULUS REMOVAL (May 23, 1994)
  • K925313 — TITANIUM COC ABUTMENT HEADS FOR IMZ (July 30, 1993)
  • K925349 — ONE SYSTEM TAPERED TITANIUM ABUTMENTS (July 27, 1993)
  • K924190 — ISS O-RING ATTACHMENT (May 27, 1993)
  • K921764 — DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS (November 3, 1992)
  • K904605 — TITANIUM COC ABUTMENT HEADS FOR IMZ (January 29, 1991)
  • K892239 — DENTAL HAND INSTRUMENTS (May 18, 1989)

Other clearances for product code EGG

  • K990979 — STECO-TITANMAGNETICS (September 3, 1999)
  • K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS (December 6, 1996)
  • K925700 — ZEST ANCHOR ADVANCED GENERATION (April 7, 1994)
  • K915299 — COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (January 31, 1992)
  • K912435 — DENTAL CONNECTOR PRECISION ATTACHMENT (August 28, 1991)
  • K912567 — CONICAST, INTRACAST, OMECAST (July 2, 1991)
  • K901928 — INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH (July 26, 1990)
  • K900785 — MICRO 2 SYSTEM (April 16, 1990)
  • K896337 — DENTAL BRIDGE ANCHORING PINS (January 31, 1990)
  • K891119 — T.R.S.: TOOTH REPLACEMENT SYSTEM (April 17, 1989)

FDA data resources