SR PHONARES NHC

K093331 · Ivoclar Vivadent, Inc. · ELM · Jan 28, 2010 · Dental

Device Facts

• Record ID: K093331
• Device Name: SR PHONARES NHC
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: ELM · Dental
• Decision Date: Jan 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SR Phonares NHC denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

Device Story

SR Phonares NHC are preformed plastic denture teeth used in dental prosthetics. These teeth are utilized by dental professionals to construct complete, partial, hybrid, or implant-supported dentures. The device serves as the functional and aesthetic component of a removable or fixed-removable dental prosthesis. By providing a pre-shaped, durable tooth structure, the device enables the fabrication of dentures that restore patient masticatory function and aesthetics. The device is used in a clinical or laboratory setting by dentists or dental technicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Preformed plastic denture teeth. Material: Nano-hybrid composite (NHC). Form factor: Anatomical tooth shapes for complete/partial dentures. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for patients requiring complete or partial denture prosthetics, including hybrid dentures and implant-supported dentures.

Regulatory Classification

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

JAN 2 8 2010

Re: K093331

Trade/Device Name: SR PHONARES NHC Regulation Number: 21CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: January 14, 2010 Received: January 20, 2010

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.

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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/ycm115809.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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

409,3331 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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Device Name: SR PHONARES NHC

Indications For Use:

SR Phonares NHC denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

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)
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| (Division Sign-Off) | |
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Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510K application |
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| SR Phonares NHC |
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| 510(k) Number: | K093331 |
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