(112 days)
Not Found
No
The summary describes preformed denture teeth and their material properties and testing, with no mention of AI or ML.
No
The device, preformed denture teeth, is used for prosthetic purposes (dentures and implant-supported prostheses) to replace missing teeth, which falls under restorative or cosmetic dentistry, not therapy for a medical condition.
No
Explanation: The device is described as "Preformed denture teeth," which are replacement parts for teeth, not instruments used to diagnose conditions. The performance studies focus on material properties and biocompatibility, not diagnostic capabilities.
No
The device description and performance studies clearly indicate a physical product (preformed denture teeth) made of materials like PMMA, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses." This describes a device used in the mouth for mechanical and aesthetic purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description reinforces the intended use of preformed teeth for dentures and prostheses.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The testing described (ISO 22112, ISO 10477, Ball Indentation, Biocompatibility) is relevant to the physical properties, durability, and safety of a dental prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Product codes (comma separated list FDA assigned to the subject device)
ELM
Device Description
Preformed denture teeth used for total and partial dentures and implant-Device Description: supported removable prostheses.
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 has been tested in accordance with ISO 22112:2005 for Artificial denture teeth and it meets the requirements defined. The device was also tested in accordance with ISO 10477:2004 Polymer based crown & bridge materials for Flexural Strength, Water somion and Solubility. Finally, the materials were tested using a Ball Indentation test according to DIN EN ISO 2039-1. Biocompatibility testing and evaluation was also carried out according to ISO 10993. The subject device is a PMMA denture tooth, the composition of which is well known and accepted as biocompatible in dentistry.
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.
SR Vivodent PE, SR Orthotyp PE (K844349), Phonares II (K120736)
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.
Not Found
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
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
JAN 1 4 2014
510(K) SUMMARY (revised 12.11.2013)
SR Vivodent S, SR Orthotyp S, SR Ortholingual S
| Contact: | Donna Marie Hartnett, Director of QA/Regulatory Affairs | |
|---|---|---|
| Company: | Ivoclar Vivadent. 175 Pineview Drive, Amherst, NY 14228 | |
| (716) 691-0010 | ||
| Date Prepared: | December 11, 2013 | |
| Proprietary Name: | SR Vivodent S, SR Orthotyp S, SR Ortholingual S | |
| Classification Name: | Denture, Plastic, Teeth (872.3590) | |
| Predicate Devices: | SR Vivodent PE, SR Orthotyp PE (K844349) and Phonares II (K120736) |
Preformed denture teeth used for total and partial dentures and implant-Device Description: supported removable prostheses.
The predicate device to which SR Vivodent S, SR Ortholingual S have been compared is SR Vivodent PE, SR Orthotyp PE (K844349) and Phonares II (K120739) For this application, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, has been compreed to 1841349 predicate with regard to chemical composition, performance data and indications for use The subject device has also been compared to Phonares II (K120739) with regard to indications for use. The comparison shows that SR Vivodent S, SR Orthotyp S, SR Ortholingual a are substantially equivalent to the predicate devices.
Intended Use: Preformed denture teeth used for total and partial dentures and implantsupported removable prostheses.
Technological Characteristics: The device design, i.e. delivery form, and intended use of SR Vivodent S, SR Orthotyp S, SR Ortholingual S, 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 i
Testing Summary: The Device has been tested in accordance with ISO 22112:2005 for Artificial denture teeth and it meets the requirements defined. The device was also tested in accordance with ISO 10477:2004 Polymer based crown & bridge materials for Flexural Strength, Water somion and Solubility. Finally, the materials were tested using a Ball Indentation test according to DIN EN ISO 2039-1. Biocompatibility testing and evaluation was also carried out according to ISO 10993. The subject device is a PMMA denture tooth, the composition of which is well known and accepted as biocompatible in dentistry.
Conclusion: SR Vivodent S, SR Orthotyp S, SR Ortholingual S, is substantially equivalent to the predicate device.
1
Concurrence & Template History Page [THIS PAGE IS INCLUDED IN IMAGE COPY ONLY]
Full Submission Number:
For Office of Compliance Contact Information:
http://insideportlets.fda.gov:9010/portal/page?_nageid=197,415881&_dad=portal&_schema=PORTAL&org=318
For Office of Surveillance and Biometrics Contact Information:
http://insideportlets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PORTAL&org=423
| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | Myra Browne |
| Branch Chief Sign-Off | Susan Runner |
| Division Sign-Off | Kwame O=Ulmer S |
| 2014.01.14 13:36:24 -05'00' |
Template Name: K1(A) – SE after 1996
Template History:
| Date of Update | By | Description of Update |
|---|---|---|
| 7/27/09 | Brandi Stuart | Added Updates to Boiler Table |
| 8/7/09 | Brandi Stuart | Updated HFZ Table |
| 1/11/10 | Diane Garcia | Liability/Warranty sentence added at bottom of 1st page |
| 10/4/11 | M. McCabe Janicki | Removed IFU sheet and placed in Forms |
| 9/25/12 | Edwena Jones | Added digital signature format |
| 12/12/12 | M. McCabe Janicki | Added an extra line between letter signature block and the word |
| "Enclosure". Also, added a missing digit in 4-digit extension on | ||
| letterhead zip code: "002" should be "0002". | ||
| 4/2/2013 | M. McCabe Janicki | Edited sentence that starts "If you desire specific advice for your |
| device on our labeling regulation (21 CFR Part 801) " Replaced | ||
| broken Compliance link with general link to DSMICA. | ||
| 4/12/2013 | Margaret McCabe | |
| Janicki | Fixed a typo: Paragraph 1, final sentence, "We remind you. | |
| however; that device labeling must be truthful" Replaced | ||
| incorrect semicolon with a comma. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple, yet recognizable, and is often used on official documents and websites related to the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2014
Ivoclar Vivadent, Incorporated Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs 175 Pineview Drive Amherst, NY 14228
Re: K132984
Trade/Device Name: SR Vivodent S, SR Orthotyp S, SR Ortholingual S Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: October 15, 2013 Received: October 16, 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 Federal Register.
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 (OS) 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/ResourcesforYou/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
Sincerely yours,
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Kwame O.
Ulmer-S
for
Erin I. Keith, M.S. Acting 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): K132984
Device Name: SR Vivodent S, SR Orthotyp S, SR Ortholingual S
Indications For Use:
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Prescription Use X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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