(180 days)
Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium/titanium alloy or zirconium oxide bases.
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.
This is a 510(k) summary for a dental cement, not an AI/ML powered device. Therefore, many of the requested criteria regarding AI device studies are not applicable. I will address the applicable criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Multilink Hybrid Abutment Cement) | Predicate Device Performance (Multilink Implant - K090704) | Conclusion on Equivalence |
|---|---|---|---|
| Water Absorption (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Water Solubility (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Radiopacity (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Flexural Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Modulus of Elasticity (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Compressive Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Shear Bond Strength (ISO 4049:2000) | Tested and results demonstrate substantial equivalence to predicate. | Not explicitly stated, but assumed to meet ISO 4049:2000. | Substantially Equivalent |
| Biocompatibility (ISO 10993) | Testing and evaluation carried out according to ISO 10993. | Not explicitly stated, but assumed to meet ISO 10993. | Substantially Equivalent |
| Intended Use | Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium alloy or zirconium oxide bases. | Intraoral permanent cementation of restorations (implied from product name and comparison). | Differentiated by intraoral/extraoral use, but overall deemed substantially equivalent in context of cement properties. |
| Chemical Composition | Modified from the predicate. | Not explicitly stated, but implied to be different from the subject device. | Substantially Equivalent (despite modification, performance is equivalent) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified, but likely from in-house laboratory testing based on the standards cited (ISO 4049:2000, ISO 10993). This would typically be considered prospective testing for the purpose of demonstrating device performance against a standard. The country of origin is not explicitly stated beyond "Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, not a diagnostic or AI device that requires expert ground truth for its performance evaluation in the context of the reported tests. Its performance is measured against physical and chemical standards.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements of physical and chemical properties based on ISO standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
For the performance tests (Water Absorption, Solubility, Radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength, Shear Bond Strength), the "ground truth" or reference is the standards set forth by ISO 4049:2000. The biocompatibility "ground truth" is defined by ISO 10993. The device's performance is compared against these established material performance criteria and against the performance of its predicate device to claim substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device. There is no "training set" in the context of material science evaluation for a 510(k) submission like this.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML powered device, there is no training set or associated ground truth establishment process in the AI sense.
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510(K) SUMMARY
Image /page/0/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the words "ivoclar" and "vivadent" stacked on top of each other in a bold, sans-serif font. Above the words is a curved line of dots and squares, with the dots gradually increasing in size from left to right, and the squares gradually increasing in size from right to left. The logo is simple and modern, and the use of dots and squares gives it a playful feel.
MULTILINK HYBRID ABUTMENT CEMENT
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010 |
| 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.