(115 days)
Futurabond Universal is intended for use as:
- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites .
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites
Not Found
This FDA 510(k) clearance letter for the Futurabond U device does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document is a clearance letter, confirming that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for the specified indications for use. It outlines administrative details like regulation numbers, product codes, and general controls provisions of the Act.
Therefore, I cannot provide the requested information as it is not present in the provided text.
To illustrate, if the document had contained information about a study, it might have looked something like this (this is a hypothetical example of what one would look for):
Hypothetical Section from a different document (NOT from the provided text):
"Clinical Study Results for Futurabond U
A prospective, randomized, controlled clinical trial was conducted to evaluate the bond strength and clinical longevity of Futurabond U compared to a predicate device.
Acceptance Criteria:
- Shear Bond Strength (SBS) to Enamel: Mean SBS ≥ 15 MPa
- Shear Bond Strength (SBS) to Dentin: Mean SBS ≥ 10 MPa
- Retention Rate at 12 Months: ≥ 95%
- Marginal Adaptation: No significant deterioration (score 0 or 1 on a 0-3 scale) in >90% of restorations at 12 months.
Reported Device Performance:
| Acceptance Criteria | Futurabond U Performance | Meets Criteria? |
|---|---|---|
| Shear Bond Strength (SBS) to Enamel | 18.2 ± 2.1 MPa | Yes |
| Shear Bond Strength (SBS) to Dentin | 12.5 ± 1.8 MPa | Yes |
| Retention Rate at 12 Months | 96.7% | Yes |
| Marginal Adaptation (score 0 or 1) at 12 Mos | 93.5% | Yes |
Study Details:
- Test Set Sample Size: 250 patients, with a total of 500 restorations (250 Futurabond U, 250 predicate).
- Data Provenance: Prospective, multi-center study conducted in the USA, Germany, and Japan.
- Experts for Ground Truth: 5 board-certified restorative dentists, each with an average of 15 years of clinical experience.
- Adjudication Method: 3+1 (three dentists independently evaluated each restoration; in case of disagreement, a fourth senior dentist adjudicated).
- MRMC Comparative Effectiveness Study: No, this was a direct comparison of device performance, not a reader study.
- Standalone Performance: Yes, the above metrics represent the performance of the algorithm (device) itself.
- Type of Ground Truth: Clinical outcome data (retention, marginal adaptation) and ex vivo laboratory measurements (bond strength).
- Training Set Sample Size: Not applicable for a dental bonding agent; performance is based on material properties and clinical application.
- Ground Truth for Training Set: Not applicable. Material properties are established through chemical and physical testing during product development.
End Hypothetical Section
The provided document {0}, {1}, {2} is purely an FDA clearance letter and does not include any of the detailed study information or acceptance criteria for performance metrics.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY
Re: K130486
Trade/Device Name: Futurabond U Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EMA Dated: April 16, 2013 Received: April 24, 2013
Dear Dr. Gerkensmeier:
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. Iisting 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.
{1}------------------------------------------------
Page 2 - Dr. Gerkensmeier
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 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 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 ﻠ (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Runner DDS, MA 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
{2}------------------------------------------------
Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Futurabond Universal Device Name:
Indications for Use:
ないです。このことを経営すると、ここではな
Futurabond Universal is intended for use as:
- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites .
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites
Prescription Use × OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen 2013.06.20 08:46:34 04'00'
(Division Sign-Off) (Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices
510(k) Number: K130486
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.