(87 days)
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
Multilink Automix is a self-curing and self-etching luting 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 provided text describes the submission for MULTILINK AUTOMIX to the FDA for 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not necessarily to set new, absolute acceptance criteria for the new device as a standalone product based on clinical outcomes.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device, Multilink (K032470), as the new device, Multilink Automix, aims to show substantial equivalence. The "acceptance criteria" for the Multilink Automix are therefore that its performance falls within an expected range relative to the predicate, demonstrating it is "substantially equivalent" and "no new issues of safety and effectiveness" persist.
| Property | UOM | Predicate Device (Multilink K032470) | Multilink Automix (Self Curing) Reported Performance | Multilink Automix (Dual Curing) Reported Performance | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) |
|---|---|---|---|---|---|
| Working time (37C) | Min | 3-4 | 3-4 | -- | Within range of 3-4 min |
| Setting time | Min | 7-9 | 6-7 | -- | Within a comparable range to 7-9 min |
| Film Thickness | µm | <20 | <50 | <50 | <50 µm (Note: Higher than predicate, but still acceptable for this class of device) |
| Water Absorption | µg/mm³ | <25.0 | <40 | <40 | <40 µg/mm³ (Note: Higher than predicate, but acceptable) |
| Water solubility | µg/mm³ | <3.0 | <7.5 | <7.5 | <7.5 µg/mm³ (Note: Higher than predicate, but acceptable) |
| Radiopacity | %Al | 350 | 350 | 350 | 350 %Al (Matches predicate) |
| Flexural Strength | MPa | 90±10 | 70±20 | 110±10 | Comparable to 90±10 MPa (Self-curing slightly lower, dual-curing higher, but both within a reasonable range for equivalence) |
| Modulus of Elasticity | MPa | 5000±1000 | 3250±400 | 6000±400 | Comparable to 5000±1000 MPa (Ranges overlap sufficiently) |
| Compressive Strength | MPa | 250±20 | 240±20 | 280±20 | Comparable to 250±20 MPa (Ranges overlap sufficiently) |
| TransparencyBase (trans and Cat)Yellow and CatOpaque and Cat | % | 12±1.510±1.52±0.5 | 12±1.510±1.52±0.5 | 12±1.510±1.52±0.5 | Matches predicate values |
| Vickers Hardness | MPa | 370 | -- | 440±30 | Comparable to 370 MPa (Dual-curing is higher, which is generally positive) |
| Shear Bond StrengthDentin / 24hEnamel/ 24h | MPa | 21±223+4 | 17±518+3 | 21±223+4 | Comparable to 21±2 and 23+4 MPa (Dual-curing matches, self-curing slightly lower but potentially acceptable) |
Note: The acceptance criteria are "implied" because the document focuses on demonstrating substantial equivalence to the predicate device, meaning the new device's performance should be within an acceptable range of the predicate's performance.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of specimens for flexural strength tests). It only indicates that "The device was tested in accordance with ISO 4049:2000" and other standards. These standards typically specify minimum sample sizes for material property tests.
The data provenance is from Ivoclar Vivadent, Inc., which is listed as being in Amherst, NY, USA. The data is from laboratory testing performed to demonstrate material properties, and thus is considered prospective in the sense that the tests were conducted specifically for this submission, although not on live patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is objective physical and chemical properties of a dental material, measured using standardized laboratory methods (e.g., ISO 4049:2000). It does not involve expert interpretation or clinical assessment by medical professionals to establish a truth.
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the "truth" is established by laboratory measurement, not by expert consensus or adjudication.
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
This is not applicable. This submission is for a dental material/device (luting composite system), not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is a dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data presented is derived from standardized laboratory testing and measurements of material properties (e.g., Water Absorption, Flexural Strength, Shear Bond Strength) as per ISO 4049:2000 and other relevant standards.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical dental material, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
{0}------------------------------------------------
MULTILINK AUTOMIX
JAN 3 1 2013
K | 23397
Donna Marie Hartnett Contact:
Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228 Company: (716) 691-0010
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
{1}------------------------------------------------
510(K) SUMMARY MULTILINK AUTOMIX
The following table shows the performance data of Multilink Automix and its predicate device: . .
・
.
.
| Property | UOM | Multilink(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 |
| CompressiveStrength | MPa | 250±20 | 240±20 | 280±20 |
| TransparencyBase (trans and Cat)Yellow and CatOpaque and Cat | % | 12±1.510±1.52±0.5 | 12±1.510±1.52±0.5 | 12±1.510±1.52±0.5 |
| Vickers Hardness | MPa | 370 | -- | 440±30 |
| Shear Bond StrengthDentin / 24hEnamel/ 24hh | MPa | 21±223+4 | 17±518+3 | 21±223+4 |
.
:
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{4}------------------------------------------------
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
| 510/k) Number: | n of | 20 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|---|---|
Page 1 of __ 1__
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.