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Adapter Ps Rp-Np, 34551, Adapter Ps Wp-Rp, 34552, Abutment Screw Ps Rp-Np, 3455…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063592

by Nobel Biocare AB

Identifiers

510(k) Number
K063592 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 Adapter PS and Abutment Screw PS are dental components designed for use within implant systems. These devices function as connectors and fasteners to facilitate the assembly of dental prosthetics in oral and maxillofacial applications.

These components are supplied by Nobel Biocare AB and are subject to FDA 510(k) clearance under K063592. The product line includes specific models identified by reference codes 34551, 34552, 34553, and 34554.

Frequently asked questions

What is the purpose of the Adapter PS and Abutment Screw PS?

These components are designed for use within dental implant systems. They function as essential connectors and fasteners to facilitate the secure assembly of dental prosthetics in oral and maxillofacial applications.

Which specific models are available in this product line?

The product line includes four distinct components identified by their reference codes: the Adapter PS RP-NP (34551), the Adapter PS WP-RP (34552), the Abutment Screw PS RP-NP (34553), and the Abutment Screw PS WP-RP (34554).

What is the regulatory status of these dental components?

These devices are manufactured by Nobel Biocare AB and have received FDA 510(k) clearance under the submission number K063592, confirming they are substantially equivalent to existing devices.

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: PDF K063592 Adapter Ps Rp-np, 34551, Adapter Ps Wp-rp,34552, Abutment Screw ..., Device Listing 1043880658 - FDA.report, K063734 FDA 510(k) - ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CE..., K070744 FDA 510(k) - NARROW NECK TEMPORARY COPING

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (1)

  • FDA 510(k) K063592 24 fields · synced Oct 6, 2026