Identifiers
- 510(k) Number
- K111852 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Anodized Healing Collar is a dental implant accessory designed to shape soft tissue during the healing phase. It is used to form the soft tissue before a final restoration is placed.
The device is threaded onto the dental implant in either one-stage or two-stage protocols and remains in the mouth until soft tissue development is complete. This device has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the Anodized Healing Collar?
This device is designed to shape soft tissue during the healing phase following the placement of a dental implant. By remaining in the mouth until soft tissue development is complete, it helps form the tissue profile in preparation for the final dental restoration.
In which surgical protocols can this healing collar be used?
The Anodized Healing Collar is versatile and can be threaded onto the dental implant for use in both one-stage and two-stage surgical protocols, depending on the specific clinical requirements of the procedure.
What is the regulatory status of this device?
The Anodized Healing Collar has received FDA 510(k) clearance under the submission number K111852. It was determined to be substantially equivalent to existing devices by the FDA Dental advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ANODIZED HEALING COLLAR (K111852) — FDA 510 (k) | Innolitics, PDF CA 92008 z uiuiir (fax) dental - accessdata.fda.gov, Zimmer® Abutments, Analogs, and Implant Accessories Online, ANODIZED HEALING COLLAR (K111852) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111852 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
- FDA Applicant
- Zimmer Dental, Inc.
Sources (1)
- FDA 510(k) K111852 24 fields · synced Oct 6, 2026