DMP PIT & FISSURE SEALANT

K102252 · Dmp, Ltd. · EBC · Dec 3, 2010 · Dental

Device Facts

• Record ID: K102252
• Device Name: DMP PIT & FISSURE SEALANT
• Applicant: Dmp, Ltd.
• Product Code: EBC · Dental
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pits and fissures of molars and premolars Fissures on the lingual sides of anterior teeth

Device Story

DMP Pit & Fissure Sealant is a dental material applied to the occlusal surfaces of molars and premolars and lingual surfaces of anterior teeth. The sealant is applied by a dental professional to fill deep pits and fissures, creating a physical barrier against bacteria and food particles to prevent dental caries. The device functions as a protective coating; it is applied in a clinical setting by a dentist or dental hygienist. The sealant hardens to provide a durable surface, reducing the risk of decay in susceptible tooth areas.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pit and fissure sealant material; resin-based chemistry; applied to tooth surfaces; light-cured or self-cured (implied by product category); biocompatible dental material.

Indications for Use

Indicated for sealing pits and fissures of molars and premolars, and fissures on the lingual sides of anterior teeth to prevent dental caries.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines.

## Public Health Service

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

Mr. Dimitris Prantsidis DMP Limited Kalyvion Avenue, Markopoulo Industrial Markopoulo, Attiki Greece 19003

Re: K102252

Trade/Device Name: DMP PIT & FISSURE SEALANT Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: October 19, 2010 Received: October 27, 2010

DEC - 3 2010

Dear Mr. Prantsidis:

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.

{1}------------------------------------------------

## Page 2- Mr. Prantsidis

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

Sincerely vours.

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

{2}------------------------------------------------

K10 2252

## 4. Indications for Use Statement

Device name: DMP PIT & FISSURE SEALANT

Indications for use:

- · Pits and fissures of molars and premolars
- · Fissures on the lingual sides of anterior teeth

DEC - 3 2010

Swer Suarez

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

510(k) Number: K100252