MULTILINK AUTOMIX

K123397 · Ivoclar Vivadent, AG · EBF · Jan 31, 2013 · Dental

Device Facts

• Record ID: K123397
• Device Name: MULTILINK AUTOMIX
• Applicant: Ivoclar Vivadent, AG
• Product Code: EBF · Dental
• Decision Date: Jan 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Indications for Use

Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired: - Inlays, onlays, crowns, bridges and root posts made of: – - Metal and metal ceramics - All-ceramics, in particular opaque zirconium oxide ceramics - Composites and fibre-reinforced composites

Device Story

Multilink Automix is a self-curing and self-etching luting composite system for permanent cementation of indirect dental restorations. Used in dental clinics by professionals; applied with Multilink Primer; Monobond Plus recommended as coupling agent for bonding to alloys, zirconium, aluminum oxide, and silicate ceramics. Device provides mechanical fixation and chemical bonding to tooth structure and restorative materials. Benefits include strong, durable retention of indirect restorations. Performance is verified through physical property testing (flexural strength, bond strength, radiopacity) to ensure clinical suitability.

Clinical Evidence

Bench testing only. Evaluated per ISO 4049:2000 for water absorption, water solubility, radiopacity, flexural strength, modulus of elasticity, compressive strength, and shear bond strength. Biocompatibility evaluated per ISO 10993. Results demonstrate performance comparable to the predicate device.

Technological Characteristics

Self-curing/self-etching luting composite system. Materials tested per ISO 4049:2000. Properties include radiopacity (350% Al), flexural strength (70-110 MPa), and compressive strength (240-280 MPa). Delivery via automix system. Biocompatibility per ISO 10993.

Indications for Use

Indicated for permanent cementation of indirect restorations including inlays, onlays, crowns, bridges, and root posts composed of metal, metal-ceramics, all-ceramics (specifically opaque zirconium oxide), composites, and fiber-reinforced composites.

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

• Multilink (K032470)

Submission Summary (Full Text)

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**MULTILINK AUTOMIX**

JAN 3 1 2013

K | 23397

Donna Marie Hartnett Contact:

Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228 Company: [phone]

December 4, 2012 Date Prepared:

Multilink Automix Proprietary Name:

Material, Tooth Shade, Resin (872.3690) Classification Name:

Predicate Devices: Multilink (K032470)

Multilink Automix is a self-curing and self-etching luting Device Description: composite system for the adhesive luting of indirect restorations made of metalceramic all-ceramic and composite. Multilink Automix is applied together with the selfetching and self-Ocuring Multilink Primer. Monobond Plus is recommended as a coupling agent to achieve a strong bond to precious and non-precious alloys, as well as to all ceramics made of zirconium and aluminum oxide and silicate ceramics.

The predicate device to which Multilink Automix has been compared is Multilink (K032470). For this application. Multilink Automix has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Multilink Automix is substantially equivalent to the predicate device.

## Intended Use:

Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:

- Inlays, onlays, crowns, bridges and root posts made of: –
- o Metal and metal ceramics
- o All-ceramics, in particular opaque zirconium oxide ceramics
- o Composites and fibre-reinforced composites

Technological Characteristics: The device design, i.e. delivery form, and intended use of Multilink Automix and the predicate device are the same. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.

Testing Summary: The device was tested in accordance with ISO 4049:2000 for Polymer based dental restorative materials for Water Absorption, Water solubility, radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength and Shear Bond Strength and the results from testing demonstrates that Multilink Automix is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.

510K Summary 5-1

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## 510(K) SUMMARY MULTILINK AUTOMIX

The following table shows the performance data of Multilink Automix and its predicate device: . .

・

.

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| Property | UOM | Multilink<br>(K032470) | Multilink Automix | Multilink Automix |
|--------------------------------------------------------------------------|--------|---------------------------|---------------------------|---------------------------|
| | | | Self Curing | Dual Curing |
| Working time (37C) | Min | 3-4 | 3-4 | -- |
| Setting time | Min | 7-9 | 6-7 | -- |
| Film Thickness | μm | <20 | <50 | <50 |
| Water Absorption | µg/mm³ | <25.0 | <40 | <40 |
| Water solubility | µg/mm³ | <3.0 | <7.5 | <7.5 |
| Radiopacity | %Al | 350 | 350 | 350 |
| Flexural Strength | MPa | 90±10 | 70±20 | 110±10 |
| Modulus of Elasticity | MPa | 5000±1000 | 3250±400 | 6000±400 |
| Compressive<br>Strength | MPa | 250±20 | 240±20 | 280±20 |
| Transparency<br>Base (trans and Cat)<br>Yellow and Cat<br>Opaque and Cat | % | 12±1.5<br>10±1.5<br>2±0.5 | 12±1.5<br>10±1.5<br>2±0.5 | 12±1.5<br>10±1.5<br>2±0.5 |
| Vickers Hardness | MPa | 370 | -- | 440±30 |
| Shear Bond Strength<br>Dentin / 24h<br>Enamel/ 24hh | MPa | 21±2<br>23+4 | 17±5<br>18+3 | 21±2<br>23+4 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 31, 2013

Ivoclar Vivadent. AG C/O Ms. Donna Marie Hartnett Director of Quality Assurance / Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive AMHEREST NY 14228

Re: K123397

Trade/Device Name: Multilink Automix Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 31, 2012 Received: November 5, 2012

Dear Ms. Hartnett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Hartnett

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80}), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hor

Ret
Harshita.D.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K123397

Device Name: Multilink Automix

Indications For Use:

-

Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:

Inlays, onlays, crowns, bridges and root posts made of:

- Metal and metal ceramics 0
- All-ceramics, in particular opaque zirconium oxide ceramics 0
- Composites and fibre-reinforced composites 0

Prescription Use 区 AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

2013.01.30 Susan Runner DDS, MA -15:42:28 -05'00'

(Division Sign-Off)
Division of Anasthesiology, ଭୌଗିନ୍ୟାପଣ୍ଡେଲ୍ସନ୍ of CDRH, Office of Device Evaluation (ODE) Infection Control, Dental Devices

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