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SCI-PHARM Paint-on Restorative

FDA 510(k)

Class II (US FDA 510(k))

510(k) K791067

by Scientific Pharmaceuticals, Inc.

Identifiers

510(k) Number
K791067 FDA 510(k)
FDA Product Code
EBD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3310 FDA 510(k)
Regulation Number
872.3310 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SCI-PHARM Paint-on Restorative is a dental coating and filling material composed of bisphenol-A glycidyl methacrylate (Bis-GMA). It is intended to restore carious lesions or structural defects in teeth.

The device is supplied as a single-use restorative material. It is not indicated for MRI safety. The device is regulated under FDA 510(k) clearance K791067.

Frequently asked questions

What is the SCI-PHARM Paint-on Restorative used for?

This device is a dental coating and filling material intended to restore carious lesions or structural defects in teeth.

Is the SCI-PHARM Paint-on Restorative a single-use device?

Yes, the device is supplied as a single-use restorative material.

Is the SCI-PHARM Paint-on Restorative indicated for MRI safety?

No, the device is not indicated for MRI safety.

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: SCI-PHARM PAINT-ON RESTORATIVE (K791067) — FDA 510(k) | Innolitics, Welcome to Sci-Pharm, SCI-PHARM PAINT-ON RESTORATIVE (K801797) — FDA 510 (k) | Innolitics, PDF K791067 - Sci-pharm Paint-on Restorative

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K791067 24 fields · synced Sep 28, 2026