JET SET 4 DENTURE REPAIR RESIN

K152981 · Lang Dental Manufacturing Company, Inc. · EBI · Sep 2, 2016 · Dental

Device Facts

• Record ID: K152981
• Device Name: JET SET 4 DENTURE REPAIR RESIN
• Applicant: Lang Dental Manufacturing Company, Inc.
• Product Code: EBI · Dental
• Decision Date: Sep 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Jet Set 4 Denture Repair Resin is intended for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). Jet Set 4 Denture Repair Resin is for prescription use only.

Device Story

Jet Set 4 Denture Repair Resin is a dental material used by dental professionals for the fabrication, repair, rebasing, and relining of removable acrylic prosthetic devices, such as full and partial dentures. The device is a chemical resin system applied in a clinical or laboratory setting to restore or create denture components. It functions as a restorative material to ensure the structural integrity and fit of prosthetic appliances, directly benefiting patients by maintaining or restoring the function and aesthetics of their removable dentures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acrylic-based resin for dental prosthetic applications. Class II device. Standard chemical polymerization process for denture repair/relining.

Indications for Use

Indicated for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (full and partial dentures) in patients requiring such dental prosthetics.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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

September 2,2016

Lang Dental Manufacturing Company, Inc. David Lang President/Owner 175 Messner Drive Wheeling, Illinois 60090

Re: K152981

Trade/Device Name: Jet Set 4 Denture Repair Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: July 7, 2016 Received: July 8, 2016

Dear Mr. David Lang:

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runner DDS, MA

Tina Kiang, Ph.D. Acting 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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## Indication(s) for Use Statement 4

510(k) Number (if known): K152981 Device Name: Jet Set 4 Denture Repair Resin

Indications for Use:

Jet Set 4 Denture Repair Resin is intended for the manufacture, repair, rebasing, and relining of removable acrylic prosthetic devices (i.e. full and partial dentures). Jet Set 4 Denture Repair Resin is for prescription use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)