DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C

• K Number: K011839
• Device Name: DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
• Manufacturer: DOXA CERTEX AB
• Date Cleared: 2002-01-17 ( 219 days)
• Product Code: EBF
• Regulation Number: 872.3690

Intended Use

DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.

Device Description

DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (< 0.05% w/w) and alkali salt accelerators (LiCl, < 0.1% w/w) are included to provide for coloring and to control the rate of hydration, respectively.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the material properties and clinical performance of a dental ceramic, with no mention of AI or ML.

Therapeutic

Yes
DoxaDent is a restorative dental material used to treat carious lesions or structural defects in teeth, which directly addresses a diseased or damaged condition.

Diagnostic

No

The device is a dental ceramic intended to restore carious lesions or structural defects in teeth, functioning as a restorative material rather than providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental ceramic composed of physical materials (calcium aluminate cement, oxides, etc.) and the performance studies focus on material properties and clinical performance, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "restore carious lesions or structural defects in teeth" and is indicated for use as a "restorative dental material for permanent application in the treatment of class I, II, and V cavities." This describes a material used directly on the patient's teeth for treatment, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details the chemical composition and physical properties of a dental ceramic material. This aligns with a restorative material, not a diagnostic test kit or instrument.
• Performance Studies: The performance studies listed focus on the material's physical and chemical properties relevant to its use as a dental restorative (flexural properties, shade, color stability, wear testing, etc.). These are not studies related to diagnostic accuracy or the detection of substances in a sample.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. DoxaDent is a material used to repair and restore teeth directly in the mouth.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.

Product codes

EBF

Device Description

DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.

Summary

0

K011839

510(k) SUMMARY

Doxa Certex AB's DoxaDent™

JAN 1 7 2002

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Doxa Certex AB Axel Johanssons gata 4 - 6, SE-75451 Uppsala, Sweden [phone] Phone: Facsimile: [phone]

Contact Person: Nils-Otto Ahnfelt

Date Prepared: June 12, 2001

Name of Device and Name/Address of Sponsor

DoxaDent™

Doxa Certex AB Axel Johanssons gata 4 - 6 SE-75451 Uppsala, Sweden

Common or Usual Name

DoxaDent Dental Ceramic

Classification Name

Tooth Shade Resin Materials

Predicate Devices

• Dentsply AP Dyract® Compomer dental composites

• Bisco, Inc.'s PYRAMID™, ADVENT™, and RENEW™ dental composites

• Coltene/Whaledent's Coltosol Temporary Endodontic Filling

1

Intended Use/Indications for Use

DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.

Technological Characteristics and Substantial Equivalence

DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (