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510(k) K863243

SHINER STRESS DIRECTING ATTACHMENT by Js & R - R & D Co. — Product Code EGG

K863243 is an FDA 510(k) premarket notification submitted by Js & R - R & D Co. for the device "SHINER STRESS DIRECTING ATTACHMENT". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
August 22, 1986
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 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)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)

FDA data resources