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Pulpdent HardShell

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945173

by Pulpdent Corporation

Identifiers

510(k) Number
K945173 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pulpdent HardShell is a dental device classified under the product code EBF, designed as a protective shell for dental restorations. It serves as a custom-fitted, rigid barrier to shield dental work during the curing process, ensuring structural integrity and precision in placement.

This device is supplied as a reusable component, intended for use in dental laboratories and clinics. It is not sterile upon packaging and must be cleaned and sterilized before each use. The Pulpdent HardShell holds an FDA 510(k) clearance under the Dental advisory committee, with a clearance number K945173, and is intended for traditional review pathways.

Frequently asked questions

What is the Pulpdent HardShell used for in a dental setting?

The Pulpdent HardShell is designed as a custom-fitted, rigid protective barrier for dental restorations. Its primary purpose is to shield dental work during the curing process, ensuring the restoration maintains its structural integrity and precision while being placed.

Is the Pulpdent HardShell intended for single-use or can it be reused?

The Pulpdent HardShell is explicitly supplied as a reusable component, intended for use in dental laboratories and clinics. Since it is not sterile upon packaging, it must be cleaned and sterilized before each use to maintain safety and hygiene standards.

How is the Pulpdent HardShell regulated in the U.S.?

The Pulpdent HardShell holds an FDA 510(k) clearance under the Dental advisory committee (DE) with clearance number K945173. It was determined to be substantially equivalent to a predicate device and follows the traditional review pathway, meaning it underwent a formal submission process to the FDA for approval.

Does the Pulpdent HardShell come pre-sterilized, or does it require preparation before use?

The Pulpdent HardShell is not sterile upon packaging and must be cleaned and sterilized before each use. This ensures proper infection control and safety in clinical or laboratory settings where it is employed.

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: PULPDENT ® Corporation - Advancing Dentistry Together, Pulpdent: About Us, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ..., Pulpdent Corporation | Dental | DPS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K945173 24 fields · synced Sep 18, 2026