Multi-Unit Abutments With Angulations 17 and 30 for Tapered Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121688 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 Multi-Unit Abutments With Angulations 17 and 30 for Tapered Implant System are dental components designed to connect multiple dental implants to a single prosthetic restoration. These abutments feature fixed angulations of 17° and 30° to accommodate off-axis implant placement, ensuring proper alignment for splinted restorations. Fabricated from titanium 6Al-4V alloy, they are secured to tapered implants via an abutment retaining screw, facilitating stable prosthetic attachment.
Used exclusively in clinical dental settings, these abutments are intended for single-patient use and are not sterilized for reuse. They are supplied as part of a tapered implant system and require precise placement within a 32° parallelism range for optimal function. The device holds an FDA 510(k) clearance under product code NHA, with a decision classification of Substantially Equivalent to a predicate device. No additional regulatory markings or sterility assurances are specified beyond the manufacturer’s compliance with dental implant standards.
Frequently asked questions
What is the purpose of the 17° and 30° angulations on these abutments?
The fixed 17° and 30° angulations are designed to correct off-axis implant placement, allowing for precise alignment of multiple dental implants under a single prosthetic restoration. This ensures proper fit and function even when implants are not perfectly parallel, within a 32° parallelism range for optimal stability.
Are these abutments reusable or single-use?
These abutments are intended for single-patient use only. They are not sterilized for reuse, aligning with clinical dental standards to prevent cross-contamination and ensure patient safety.
What material are the Multi-Unit Abutments made from?
The abutments are fabricated from titanium 6Al-4V alloy, a biocompatible material commonly used in dental implants for its strength, durability, and resistance to corrosion.
How are these abutments secured to tapered implants?
The abutments are secured to tapered implants using an abutment retaining screw, which provides a stable connection for prosthetic attachment. This mechanism ensures the abutment remains firmly in place during function.
What regulatory clearance does this device hold?
The Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System holds FDA 510(k) clearance under product code NHA, classified as Substantially Equivalent to a predicate device. This clearance confirms compliance with U.S. regulatory standards for dental implant components.
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: Multi-unit Abutments With Angulations 17 and 30 for Tapered Implant ..., PDF 4]PRISMATIK - Food and Drug Administration, PDF K121688 Multi-unit Abutments With Angulations 17 and 30 for Tapered ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121688 | Class II | Active |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA 510(k) K121688 24 fields · synced Oct 1, 2026