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

K011839 · Doxa Certex AB · EBF · Jan 17, 2002 · Dental

Device Facts

• Record ID: K011839
• Device Name: DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
• Applicant: Doxa Certex AB
• Product Code: EBF · Dental
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

DoxaDent is a calcium aluminate-based dental ceramic restorative material. It is applied by dental professionals to treat class I, II, and V cavities. The material consists of a blend of calcium aluminate cement, silica, zirconium oxide, and iron oxide colorants, with alkali salt accelerators to control hydration. It functions as a permanent restorative material for structural tooth defects. Clinical benefits include restoration of tooth integrity and function. The device is used in a clinical setting by dentists.

Clinical Evidence

Bench testing included flexural properties, shade, color stability, radio-opacity, working/setting times, marginal adaptation in extracted teeth, microstructure, compressive strength, acid erosion (EN 29917:1994/ISO 9917:1991), dimensional stability, wear, leakage/pH, electrical pulp sensitivity, and hardness. Biocompatibility and chemical stability were evaluated. Clinical data consisted of X-ray analysis of implants and evaluation of gingival reactions and plaque formation.

Technological Characteristics

Dental ceramic composed of calcium aluminate cement, silica, zirconium oxide, and iron oxide colorants. Particle sizes: 0.5-5 um and 0.02-0.2 um. Additives: LiCl (<0.1% w/w) as accelerator. Acid erosion testing per EN 29917:1994/ISO 9917:1991. Material is a permanent restorative cement.

Indications for Use

Indicated for permanent restoration of class I, II, and V dental cavities in patients requiring treatment for carious lesions or structural tooth defects.

Regulatory Classification

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.

Predicate Devices

• Dentsply AP Dyract® Compomer dental composites
• Bisco, Inc.'s PYRAMID™ dental composite
• Bisco, Inc.'s ADVENT™ dental composite
• Bisco, Inc.'s RENEW™ dental composite
• Coltene/Whaledent's Coltosol Temporary Endodontic Filling

Submission Summary (Full Text)

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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

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# 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 (< 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.

DoxaDent™ is substantially equivalent to a combination of Dentsply AP Dyract® Compomer, Bisco, Inc.'s PYRAMID™, ADVENT™, and RENEW™ dental composites, as well as Coltène/Whaledent's Coltosol Temporary Endodontic Filling. Any minor difference do not raises any new issues of safety or effectiveness.

#### Performance Data

The following performance test were conducted by Doxa Certex AB on the DoxaDent™:

- · Flexural properties
- ◆ Shade
- � Color stability
- Radio-opacity ◆
- Working and setting times �
- Study on the marginal adaptation of � DoxaDent™ in extracted teeth
- Microstructure of DoxaDent™ ◆ ◆
- Determination of compressive strength
- Some aspects of biocompatibility and chemical stability of a calcium-aluminate-hydrate-based dental restorative material, submitted for publication to the 2001 IADR meeting in Chiba, -Japan

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- ◆ Acid erosion by impinging jet technique according to EN 29917:1994/ISO 9917:1991 and Technical Corrigendum 1:1993 Dental waterbased cements
- Dimensional stability �
- ♦ Wear testing
- ◆ Leakage (Leaching) and pH
- Electrical pulp sensitivity test ◆ ◆
- ♦ Hardness

In all instances, the DoxaDent™ functioned as intended and performance observed was as expected.

### Clinical Data

DoxaCertex AB performed X-ray analysis of DoxaDent implants and evaluation of gingival reactions and plaque formation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Doxa Certex AB C/O Mr. Jonathan S. Kahan Hogan and Harton 555 13th Street Northwest Washington, District of Columbia 20004-1109

Re: K011839

Trade/Device Name: DoxaDent™ Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Materials Regulatory Class: II Product Code: EBF Dated: October 31, 2001 Received: October 31, 2001

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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#### Page 2 - Mr. Kahan

You must comply with ail the Act's requirements, including, but not limited to: registration r od intist comply with and 10 ; labeling (21 CFR Part 801); good manufacturing practice alle libang (2) 02 10 11 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 11ms letter will and will be rogen of the FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally in the at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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K011839 510(k) Number (if known):

DoxaDent™ Device Name:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

Over-The-Counter Use _ (Optional Format 1-2-96)

wnges 'Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _

OR

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