(136 days)
Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way a clinical or diagnostic performance study would.
The document is a 510(k) summary for a dental CAD/CAM block called Enamic®. It focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria through a clinical or diagnostic study.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Device Performance (Table): There are no specified performance metrics (e.g., sensitivity, specificity, accuracy) or corresponding target values mentioned. The document focuses on physical properties and material characteristics rather than diagnostic or clinical performance.
- Sample Size for Test Set and Data Provenance: This is not applicable as there's no clinical "test set" in the context of diagnostic performance.
- Number of Experts and Qualifications: Not applicable. Ground truth for diagnostic performance is not established.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as this is not a diagnostic device.
- Standalone Performance Study: Not mentioned.
- Type of Ground Truth Used: Not applicable in the context of diagnostic performance. The "ground truth" for this device revolves around its material properties and safety.
- Sample Size for Training Set: Not applicable as this is not an AI/ML device requiring a training set in the conventional sense.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does provide in terms of "proving acceptance criteria":
The document states that a "Summary of Non-Clinical Performance Data" was generated through bench testing:
- Bench Testing: Performed in accordance with FDA recognized standards ISO 10477 and ISO 6872.
- Conclusion: "The results of this testing allowed us to conclude that Enamic is safe and effective for its intended use."
The "acceptance criteria" in this context would be compliance with these ISO standards, and the "study" would be the described bench testing. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in this 510(k) summary. It only states that the device "remains compliant to the ISO standards applied to these material types" and that "Comparisons of the physical properties of the Enamic to the predicate devices are included in this application."
In summary, the provided document does not contain the type of information requested for a diagnostic or clinical performance study. It is a 510(k) summary focused on demonstrating substantial equivalence of a dental material to existing predicate devices, primarily through material characterization and compliance with international standards.
{0}------------------------------------------------
Kilauea
DEC 1 3 2012
510(k) Summary
-
Submitter................................................................................................................................................................... Spitelgasse 3 Bad Sackingen, D-79713 Germany
Establishment Reg. No. 1000625496 -
Contact..................................................................................................................................................................... Head of Regulatory Affairs and Quality Systems Ph (+49) 7761/562-361
Fx (+49) 7761/562-384 -
Official Correspondent.......................Elizabeth Wolfsen
Regulatory Affairs Specialist Vident, a Vita Company 3150 E. Birch Street Brea, CA 92821 Establishment Reg. No. 2082832 Ph (714) 961-6268 Fx (714) 961-6200 e-mail: ewolfsen@vident.com -
· Date Prepared...............................................................................................................................................................
-
Trade/Device Name: Enamic® .
-
Common Name: Dental CAD/CAM Block .
-
Classification Name: Porcelain Powder for Clinical Use (21 CFR 872.6660, Product . Code: EIH)
-
Secondary Classification Name: Tooth Shade Resin Material (21 CFR 872.3690, ● Product Code: EBF)
Predicate Devices: Vitablocs® 510(k) 102128 and
Lava Ultimate CAD/CAM Restorative for Cerec/ E4D, Lava Ultimate Implant Crown Restorative 510(k) 110131
{1}------------------------------------------------
Device Description
The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
Statement of Intended Use:
Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
Substantial Equivalence
Information provided in this application shows that the product is substantially equivalent to the predicate devices. The blending of these two proven dental materials creates beneficial physical properties while continuing to remain compliant to the ISO standards applied to these material types. Comparisons of the physical properties of the Enamic to the predicate devices are included in this application.
Technological Characteristics
Design
The geometry of the Enamic block is the same as the predicate Vitabloc.. Both blocks have an attachment, called a mandrel, which is used to secure it into a CAD/CAM machine for milling into its final form. Both blocks are polished and ready for placement thereafter.
Material
The majority volume of the Enamic block is made up of the exact same material as the Vitabloc predicate: feldspar. The remaining volume of the block is made up of resin. This combination of feldspar and resin material is similar to the Lava Ultimate predicate. Comparisons of the material composition to the two predicates to the Enamic are included in this application.
An assessment of the biocompatibility of the new device was performed, based on FDA Recognized ISO 10933 and ISO 7405 standards. This assessment, included in this application, concluded that the device is safe for its intended use.
Summary of Non-Clinical Performance Data
Bench testing was performed in accordance to FDA recognized standards ISO 10477 and ISO 6872. The results of this testing allowed us to conclude that Enamic is safe and effective for its intended use. Test results are included in this application.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol resembling three overlapping human figures or birds in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 13, 2012
Vita Zahnfabrik H. Rauter GmbH & Company C/O Ms. Elizabeth Wolfsen Regulatory Affairs Specialist Vident 3150 East Birch Street BREA CA 92821
Re: K122269
Trade/Device Name: Enamic® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH, EBF Dated: November 12, 2012 Received: December 5, 2012
Dear Ms. Wolfsen:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
{3}------------------------------------------------
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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,
Kwame O. Ulmer
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): Kil 22269
Device Name: Enamic® Indications for Use:
Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
× Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.11 Susan Runner DDS, MA 15:05:11 -05'00'
(Division Sign Off) (Division Sign On)
510(k) Number
Prescription Use (Par. 21 CFR 801.109 OR
Over-The-Counter Use_
Page 1 of _ ←
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.