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510(k) K063768

TITANIUM SCALLOPED ABUTMENT by Vident — Product Code NHA

K063768 is an FDA 510(k) premarket notification submitted by Vident for the device "TITANIUM SCALLOPED ABUTMENT". The FDA issued a decision of Substantially Equivalent on June 27, 2007. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Vident has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2007
Date Received
December 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Vident

  • K060441 — VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX6 (April 27, 2006)
  • K052710 — VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 (January 13, 2006)
  • K052130 — VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 (August 15, 2005)
  • K050362 — VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) (March 15, 2005)
  • K022996 — VITA IN-CERAM YZ CUBES FOR CEREC (October 9, 2002)
  • K012473 — VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT (September 11, 2002)
  • K000597 — VITA RESPONSE (May 17, 2000)
  • K990367 — PDQ AND PDQ-TI ABUTMENT (April 21, 1999)
  • K984198 — WIDE BODY ABUTMENTS (February 18, 1999)
  • K982664 — VITA TITANIUM PORCELAIN (August 2, 1998)

Other clearances for product code NHA

  • K261147 — Neodent Implant System - NeoConvert Fit (July 1, 2026)
  • K261122 — MIST IC (June 27, 2026)
  • K260061 — BioHorizons CEREC Compatible Ti-Bases (June 26, 2026)
  • K253922 — Neodent Scannable Healing Abutment (June 15, 2026)
  • K254145 — Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (June 11, 2026)
  • K260564 — DESS Dental Smart Solutions (June 9, 2026)
  • K252904 — SIC Abutments including CAD/CAM Solutions (June 3, 2026)
  • K253774 — Elos Accurate® Denture Fixation System (May 20, 2026)
  • K253372 — ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (May 14, 2026)
  • K260460 — Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (May 7, 2026)

FDA data resources