Home / 510(k) Clearances / K111852

510(k) K111852

ANODIZED HEALING COLLAR by Zimmer Dental, Inc. — Product Code NHA

K111852 is an FDA 510(k) premarket notification submitted by Zimmer Dental, Inc. for the device "ANODIZED HEALING COLLAR". The FDA issued a decision of Substantially Equivalent on August 11, 2011. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Zimmer Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2011
Date Received
June 29, 2011
Clearance Type
Special
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 Zimmer Dental, Inc.

  • K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems (May 17, 2017)
  • K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium (June 25, 2015)
  • K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System (May 1, 2015)
  • K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System (January 21, 2015)
  • K142082 — ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR AB (October 28, 2014)
  • K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM (October 22, 2014)
  • K141120 — ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM (July 29, 2014)
  • K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM (July 18, 2014)
  • K134045 — ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE I (April 25, 2014)
  • K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCRE (March 4, 2014)

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