← Product Code [ELM](/productcode/ELM) · K023035 # SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER (K023035) _Ivoclar Vivadent, Inc. · ELM · Dec 2, 2002 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K023035 ## Device Facts - **Applicant:** Ivoclar Vivadent, Inc. - **Product Code:** [ELM](/productcode/ELM.md) - **Decision Date:** Dec 2, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3590 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The teeth are to be utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material. ## Device Story SR VivoTAC/SR OrthoTAC are radiopaque denture teeth used by dental professionals for pre-surgical planning of dental implants. The device functions as a radiographic guide; the radiopaque material allows the clinician to visualize the tooth position, cervical length, and angulation on diagnostic imaging (e.g., X-rays or CT scans). This visualization assists in determining optimal implant placement. The device is used in a clinical setting by dentists or dental specialists. By providing a clear radiopaque marker, the device helps clinicians plan implant surgery, potentially improving surgical accuracy and patient outcomes. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Radiopaque denture teeth composed of polymer and modifier monomer. Form factor is a preformed tooth designed to lengthen the cervical region. Device is non-electronic and non-software based. ## Regulatory 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. ## Special Controls *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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is in black and white. Public Health Service Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850 Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228 Re: K023035 Trade/Device Name: SR VivoTAC, Modifier Monomer & Polymer Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: September 9, 2002 Received: September 12, 2002 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ K023035 510(k) Number (if known): Device Name: SR VivoTAC/SR OrthoTAC, Modifier Monomer & Polymer Indications For Use: SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The decemining the rature placements to se utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material. . ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) unrol (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices Unter 510(k) Number: K022303 --- **Source:** [https://fda-staging.innolitics.com/device/K023035](https://fda-staging.innolitics.com/device/K023035) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com