NEW STETIC ARTIFICIAL TEETH

K122925 · New Stetic · ELM · Feb 12, 2013 · Dental

Device Facts

• Record ID: K122925
• Device Name: NEW STETIC ARTIFICIAL TEETH
• Applicant: New Stetic
• Product Code: ELM · Dental
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

New Stetic Artificial Teeth are prefabricated plastic denture teeth composed of acrylic resin (methyl methacrylate). These devices are intended for use as prosthetic teeth within a denture assembly. They are available in various shades and sizes to accommodate specific patient requirements. The device is used by dental professionals in a clinical setting to restore dental function and aesthetics for patients. No complex processing, software, or electronic components are involved.

Clinical Evidence

Bench testing only. Performance testing was completed according to ISO 22112:2005 (Dentistry -- Artificial teeth for dental prostheses).

Technological Characteristics

Materials: Acrylic resin (methyl methacrylate). Form factor: Preformed plastic denture teeth. Standards: ISO 22112:2005. No software, electronics, or energy sources.

Indications for Use

Indicated for use as a tooth in a denture for patients requiring prosthetic dental replacement.

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.

Predicate Devices

• King Dental Corp - King-Hue, Royal Coral, Super-C Artifical Teeth (K931162)

Submission Summary (Full Text)

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K122925

## 510(k) SUMMARY (as required by 807.92(c))

New Stetic

# Regulatory Correspondent:

AJW Technology Consultants, Inc 445 Apollo Beach Blvd Apollo Beach, FL 33572 John O'Brien [e-mail] 813-645-2855 813-645-2856

#### Submitter of 510(k):

Date of Summary:

Trade/Proprietary Name:

Classification Name:

Product Code:

Intended Use:

Device Description:

Predicate Device:

September 11, 2012

Carrera 33, No 50-09

Andres Arango Velez [e-mail] Tel: + 57 4 350 47 00

Guarne, Antioquia, Colombia

New Stetic Artificial Teeth

Denture, Plastic, Teeth

ELM

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.

The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.

K931162 - King Dental Corp - King-Hue, Royal Coral, Super-C Artifical Teeth

## FEB 1 2 2013

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### Technological Characteristics and Substantial Equivalence:

New Stetic claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K931162. New Stetic claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices.

There are no differences between the New Stetic Artificial Teeth K122925 and the King Dental Artificial Teeth K931162 with respect to indications for use or technology.

#### Performance Testing:

Performance testing was completed to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses. (Dental/ENT).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### February 12, 2013

New Stetic C/O Mr. John O'Brien Regulatory and Quality Systems Lead AJW Technology Consultants, Incorporated 445 Apollo Beach Boulevard APOLLO BEACH FL 33572

Re: K122925

Trade/Device Name: New Stetic Artificial Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: January 10, 2013 Received: January 25, 2013

Dear Mr. O'Brien:

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 20993-0002

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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 (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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

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

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Indications for Use

510(k) Number (if known): K122925

Device Name: New Stetic Artificial Teeth

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number: | k122925 |
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