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510(k) K895283

PROSTHETIC RESTORATION DEVICE by Swiss Precision Mfg. Corp. — Product Code EBL

K895283 is an FDA 510(k) premarket notification submitted by Swiss Precision Mfg. Corp. for the device "PROSTHETIC RESTORATION DEVICE". The FDA issued a decision of Substantially Equivalent on February 14, 1990. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1990
Date Received
August 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Retentive And Splinting, And Accessory Instruments
Device Class
Class I
Regulation Number
872.3740
Review Panel
DE
Submission Type

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  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K924376 — ROOT CANAL POST (November 22, 1993)
  • K895758 — PLASTIC TOOTH REINFORCEMENT KIT (December 20, 1989)
  • K883074 — ELGILOY (August 9, 1988)
  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K844457 — SECURIPIN (December 27, 1984)
  • K830773 — MARKLEY THREADED WIRE (April 28, 1983)
  • K822412 — REINFORCING PIN (August 30, 1982)
  • K760723 — SAFE-T-PINS RETENTIVE PIN SYSTEM (October 21, 1976)

FDA data resources