(180 days)
No
The 510(k) summary describes a dental luting composite and its performance testing based on material properties, not AI/ML capabilities. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a luting composite intended for permanent cementation of ceramic structures, which is a restorative/prosthetic function, not a therapeutic one aiming to treat or prevent disease.
No
The device is described as a luting composite for permanent cementation of ceramic structures, which is a restorative function, not a diagnostic one.
No
The device description clearly states it is a "self-curing luting composite," which is a physical material, not software. The performance studies also focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the extraoral, permanent cementation of dental structures. This is a mechanical/restorative function, not a diagnostic one.
- Device Description: The device is described as a self-curing luting composite, which is a material used for bonding. This aligns with a restorative purpose, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is entirely related to the physical process of cementing dental structures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EMA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Multilink Implant (K090704)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Multilink Automix - K123397
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
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
3
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