ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS

K130680 · Dentsoll, Inc. · EBI · Jul 26, 2013 · Dental

Device Facts

• Record ID: K130680
• Device Name: ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
• Applicant: Dentsoll, Inc.
• Product Code: EBI · Dental
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

Device Story

Dentsoll High Dental Denture Resins consist of acrylic and polyamide resin granules (Rezen NF, Acrytone) for injection molding and a liquid resin (ISO FAST) for repairs. Used by dental professionals to create, reline, repair, or rebase removable dentures, bite plates, personal trays, and occlusal splints. Resins are available in clear or pink. Device provides structural material for dental appliances; benefits patient by restoring or creating functional dental prosthetics.

Clinical Evidence

No clinical data. Bench testing only. Testing conducted per ISO 20795-1 for physical appearance, surface properties, hue stability, transparency, air bubbles, flexural strength, flexural elasticity, bonding strength, residuals, water sorption, and solubility. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-11 (systemic toxicity). All tests passed.

Technological Characteristics

Acrylic and polyamide resins. Formulated for injection molding or liquid application. Tested to ISO 20795-1 (denture base polymers) and ISO 10993 (biocompatibility). Limited contact duration (<24 hours).

Indications for Use

Indicated for patients requiring manufacturing, relining, repairing, or rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints, and night guards.

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.

Predicate Devices

• PalaXpress ultra Heraeus Kulzer, LLC (K110037)
• DEFLEX NUXEN S.R.L. (K113608)

Submission Summary (Full Text)

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## Appendix 1

## JUL 2 6 2013

## 510(k) Summary

## K130680 510(k) Summary Pursuant to 21 CFR 807.92

#### General Company Information

| Company Name: | Dentsoll, Inc. |
|------------------|--------------------------------------------|
| Company Address: | 5836 Buford Hwy. #A,<br>Norcross, GA 30071 |

Company Telephone:

Contact:

Contact Address:

770-314-5226

May 8, 2013

David C. Furr, MS FDC Services, LLC

8708 Capehart Cove Austin, Texas 78733 [phone]

Date:

Device Trade Names:

Classification Name and Reference:

Predicate Devices:

ACRYTONE, REZEN NF, and

ISO FAST denture resins

Resin, Denture, Relining, Repairing, Rebasing Product Code EBI 21 CFR§872.3760

PalaXpress ultra Heraeus Kulzer, LLC K110037, Cleared 04/29/2011

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DEFLEX NUXEN S.R.L. K113608, Cleared 04/10/2012

Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.

Intended Use:

Device Description:

Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

#### Performance Data:

(Nonclinical and/or Clinical): The results of non-clinical testing demonstrated that the devices are safe and effective. Device testing of the Dentsoll High Dental Denture Resins was conducted in accordance with ISO ISO 20795-1 Denture Base Polymers. Testing included physical appearance, surface property, hue stability, transparency, presence of air bubbles, flexural strength, flexural elasticity, bonding strength with a dental implant, presence of residuals, water sorption, and solubility.

#### Biocompatibility:

Dentsoll High Dental Denture Resins are formed into surface contacting dental

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devices with limited (less than 24 hours) contact duration. Biocompatibility of the resins was analyzed in accordance with ISO 10993. Testing included the following:

ISO 10993-5 Cytotoxicity - pass ISO 10993-10 Sensitization - pass ISO 10993-11 Systemic Toxicity - pass

There are no significant differences between the Dentsoll High Dental Denture Resins and the predicate devices. All devices are tested to meet ISO 20795 and ISO 10993. Formulations, presentation, and colors are very similar. The devices are substantially equivalent.

### Conclusion:

5

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Public Health Service

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

July 26, 2013

Dentsoll, Incorporated C/O Mr. David C. Furr, MS FDC Services, Limited Liability Company 8708 Capehart Cove . Austin, Texas 78733

Re: K130680

Trade/Device Name: Dentsoll - High Dental Denture Resins Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: 11 Product Code: EBI Dated: March 12, 2013 Received: May 14, 2013

Dear Mr. Furr:

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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Page 2 - Mr. Furr

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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/McdicalDevices/Safety/ReportalProblem/dcfault.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,

Mary S. Runner -S

Kwame Ulmer. M.S. Acting Division 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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510(k) Premarket Notification Dentso!! - High Dental Denture Resins

# Indications for Use Statement

130680

510(k) Number:

Device Name: Dentsoll - High Dental Denture Resins

Indications For Use:

Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

Prescription Use X (per CFR 801.109)

or

Over-the-counter use

Concurrence of CDRH

Sheena A. Greet 2013.07.26 11 138 00 000

for M. Susan Runner, DDS, MA

(Division Sign-Off) Islon of Anesthestology, General Hospital Infection Control, Dental Device 510(k) Number: