Home / 510(k) Clearances / K952868

510(k) K952868

DENTAURUM JACKET CROWN & ROOT POSTS by Dentauraum, Inc. — Product Code EBL

K952868 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENTAURUM JACKET CROWN & ROOT POSTS". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1995
Date Received
June 22, 1995
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 by Dentauraum, Inc.

  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)
  • K935856 — DENTAURUM SPACE MAINTAINER (April 28, 1994)

Other clearances for product code EBL

  • K002693 — CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (November 9, 2000)
  • K924376 — ROOT CANAL POST (November 22, 1993)
  • K895283 — PROSTHETIC RESTORATION DEVICE (February 14, 1990)
  • 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