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510(k) K972875

COSMOPOST by Ivoclar North America, Inc. — Product Code ELR

K972875 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "COSMOPOST". The FDA issued a decision of Substantially Equivalent on September 17, 1997. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type

Other clearances by Ivoclar North America, Inc.

  • K012174 — ERIS LAYERING MATERIALS (August 27, 2001)
  • K011491 — HELIOSEAL CLEAR CHROMA (August 16, 2001)
  • K011492 — IN TEN-S (July 5, 2001)
  • K011490 — MODIFICATION TO EXCITE (June 27, 2001)
  • K011023 — D.SIGN 96 (May 2, 2001)
  • K011022 — BIOUNIVERSAL PDF (May 2, 2001)
  • K010381 — D.SIGN 30 (March 6, 2001)
  • K010250 — TETRIC CERAM HB (February 28, 2001)
  • K003293 — EXCITE DSC (February 6, 2001)
  • K003407 — SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (January 26, 2001)

Other clearances for product code ELR

  • K060075 — FIBER-METAL POST (March 30, 2006)
  • K042848 — FRC POSTEC PLUS (November 22, 2004)
  • K030820 — EVERSTICK POST (May 20, 2003)
  • K020431 — FIBIOCORE (July 3, 2002)
  • K012496 — CARBON POST (May 17, 2002)
  • K013802 — FRC POSTEC (May 1, 2002)
  • K012849 — GLASS POST (March 27, 2002)
  • K012354 — SNOWPOST, SNOWLIGHT (October 10, 2001)
  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)

FDA data resources