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510(k) K895758

PLASTIC TOOTH REINFORCEMENT KIT by Nanzee Dental Products — Product Code EBL

K895758 is an FDA 510(k) premarket notification submitted by Nanzee Dental Products for the device "PLASTIC TOOTH REINFORCEMENT KIT". The FDA issued a decision of Substantially Equivalent on December 20, 1989. 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
December 20, 1989
Date Received
September 26, 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

Other clearances for product code EBL

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  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K924376 — ROOT CANAL POST (November 22, 1993)
  • K895283 — PROSTHETIC RESTORATION DEVICE (February 14, 1990)
  • 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