MULTILINK HYBRID ABUTMENT CEMENT

K130436 · Ivoclar Vivadent, AG · EMA · Aug 20, 2013 · Dental

Device Facts

• Record ID: K130436
• Device Name: MULTILINK HYBRID ABUTMENT CEMENT
• Applicant: Ivoclar Vivadent, AG
• Product Code: EMA · Dental
• Decision Date: Aug 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium/titanium alloy or zirconium oxide bases.

Device Story

Multilink Hybrid Abutment Cement is a self-curing luting composite used for extraoral, permanent cementation of dental ceramic structures (lithium disilicate or zirconium oxide) to titanium or zirconium oxide bases. The device is used in a dental laboratory setting during the fabrication of hybrid abutments or hybrid abutment crowns. It functions as a bonding agent to secure the ceramic structure to the abutment base. The clinician or dental technician applies the cement to the components to create a durable, permanent bond. This process enables the creation of custom hybrid abutments, which benefit the patient by providing a stable, biocompatible interface between the implant and the final dental restoration.

Clinical Evidence

Bench testing only. The device was evaluated according to ISO 4049:2000 standards for water absorption, water solubility, radiopacity, flexural strength, modulus of elasticity, compressive strength, and shear bond strength. Biocompatibility was evaluated per ISO 10993. Results demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Self-curing luting composite. Materials evaluated per ISO 4049:2000 and ISO 10993. Delivery form is consistent with dental luting composites. Designed for extraoral use in hybrid abutment fabrication.

Indications for Use

Indicated for the extraoral, permanent cementation of ceramic structures (lithium disilicate glass-ceramic or zirconium oxide) onto titanium, titanium alloy, or zirconium oxide bases for the fabrication of hybrid abutments or hybrid abutment crowns.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Multilink Implant (K090704)

Reference Devices

• Multilink Automix (K123397)

Submission Summary (Full Text)

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## 510(K) SUMMARY

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## MULTILINK HYBRID ABUTMENT CEMENT

| Contact: | Donna Marie Hartnett |
|----------------------|--------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228<br>[phone] |
| Date Prepared: | August 20, 2013 |
| Proprietary Name: | Multilink Hybrid Abutment Cement |
| Classification Name: | Dental Cement (872.3275) (Classification Code EMA) |
| Predicate Devices: | Multilink Implant (K090704) |

Device Description: Multilink® Hybrid Abutment is a self-curing luting composite for the extraoral, permanent cementation of ceramic structures made of lithium disilicate glass-ceramic (LS2) or zirconium oxide on titanium alloy or zirconium oxide bases (e.g. abutment or adhesive basis) in the fabrication of hybrid abutments or hybrid abutment crowns.

The predicate device to which Multilink Hybrid Abutment cement has been compared is Multilink Implant (K090704). For this application, Multilink Hybrid Abutment cement has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Multilink Hybrid Abutment is substantially equivalent to the predicate device.

Intended Use: Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS-) or zirconium oxide on titanium alloy or zirconium oxide bases.

Guidance Document: The submission was prepared in accordance with FDA Guidance document entitled Dental Composite Resin Devices - Premarket Notification (510K) Submissions dated October 26, 2005.

Technological Characteristics: The device design, i.e. delivery form, and intended use of Multilink Hybrid Abutment cement and the predicate device are the same except Multilink Hybrid Abutment material is used extra-orally which the predicate is used intra-orally. The composition of the subject device has been modified from the predicate.

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 Strenath and Shear Bond Strength and the results from testing demonstrates that Multilink Hybrid Abutment is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.

We will notify the FDA after completion of the real-time testing of the proposed device if the shelf life differs than the 24 months claimed. Multilink Automix - K123397.

CONCLUSION: The above data and analysis demonstrates that Multilink Hybrid Abutment Cement is substantially equivalent to the predicate device.

510K Summary 5-1

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

## August 20, 2013

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

Re: K130436

Trade/Device Name: Multilink Hybrid Abutment Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 16, 2013 Reccived: July 22, 2013

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 Eederal 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 device-related 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 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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): K130436

Device Name: Multilink Hybrid Abutment Cement

Indications For Use:

Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium/titanium alloy or zirconium oxide bases.

AND/OR -Prescription Use X (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) .

Andrew I. Steen - Sconcurrence of CDRH, Office of Device Evaluation (ODE)
2013.08.20 14:39:07 -04/00 Page 1 of _1__________________________________________________________________________________________________________________________________________________________________

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Division Sign-Off) )ivision of Anesthesiology, General Hospital ntection Control, Dental Devices

10(k) Number. K130436