Dentivera Milling Disc

K160498 · Dental Solutions, LLC · EBI · Jun 15, 2016 · Dental

Device Facts

• Record ID: K160498
• Device Name: Dentivera Milling Disc
• Applicant: Dental Solutions, LLC
• Product Code: EBI · Dental
• Decision Date: Jun 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.

Device Story

Dentivera™ Milling Disc is a cylindrical, puck-shaped thermoplastic resin (Ultaire™ AKP, an arylketone polymer with zinc oxide stabilizer). Used in dental laboratories; machined into partial or full removable denture frames via standard dental CAD/CAM milling systems. Provides a durable, biocompatible base material for removable prosthetics. Healthcare providers use the milled output to restore patient dentition; benefits include strength and durability comparable to traditional denture base resins. Device is a raw material for fabrication, not a finished clinical device.

Clinical Evidence

Bench testing only. Performance testing demonstrated compliance with ISO 20795-1 for flexural strength, flexural modulus, water sorption, and water solubility. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), intracutaneous reactivity (ISO 10993-10), systemic toxicity (ISO 10993-11), implantation studies (ISO 10993-6), genotoxicity (ISO 10993-3), and pyrogenicity (USP <151>). All tests passed.

Technological Characteristics

Material: Ultaire™ AKP (arylketone thermoplastic polymer with zinc oxide). Form factor: 98 mm diameter, 28 mm thick cylindrical disc. Fabrication: CAD/CAM milling. Mechanical standards: ISO 20795-1. Biocompatibility standards: ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-18, ISO 14071, USP <151>.

Indications for Use

Indicated for the manufacture of full and partial removable dentures and overdentures. Contraindicated for use in full removable dentures or permanent (cemented or implant retained) crowns, caps, bridges, or superstructures.

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

• Paladon 65 (K901789)

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

June 15, 2016

Dental Solutions, LLC % Brian Edwards Principal Medical Research Manager, Regulatory Namsa 4050 Olson Memorial Highway Golden Valley, Minnesota 55442

Re: K160498

Trade/Device Name: Dentivera Milling Disc Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: February 22, 2016 Received: May 5, 2016

Dear Brian Edwards:

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.

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

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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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Susan Runner, DDS, MA

Erin I. Keith, M.S. 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) K160498

Device Name

Dentivera™ Milling Disc

Indications for Use (Describe)

The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 1.0 510(k) Summary - K160498

#### 1.1 Submission Sponsor

Kendra Shoulders Director of Global Regulatory Affairs Dental Solutions, LLC P.O. Box 270725 7701 Golden Valley Rd. Golden Valley, MN 55427 Phone: [phone] [e-mail]

#### 1.2 Submission Correspondent

Brian J. Edwards Principal Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway Suite 450 Minneapolis, MN 55422 Phone: [phone] Fax: [phone] [e-mail]

# 1.3 Date Prepared

June 8, 2016

# 1.4 Device Identification

| Trade/Proprietary Name: | Dentivera™ Milling Disc |
|----------------------------|-------------------------------------------------|
| Common/Usual Name: | Denture Base Resin |
| Classification Name: | Denture Relining, Repairing, and Rebasing Resin |
| Classification Regulation: | 21 CFR Part 872.3760 |
| Product Code: | EBI |
| Device Class: | II |
| Classification Panel: | Dental Devices |
| Model Numbers: | TBD |

# 1.5 Predicate Devices

The predicate device for the Dentivera™ Milling Disc is the Paladon 65 denture relining, repairing, and rebasing resin cleared on June 22, 1990 under 510(k) Number K901789.

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Both resin products are indicated for the manufacture of full and partial removable dentures and implant overdentures.

# 1.6 Device Description

The Dentivera™ Milling Discs are cylindrical, puck-shaped discs made from Ultaire™ AKP, an arylketone thermoplastic polymer resin with zinc oxide (ZnO) as an additive stabilizer.

Image /page/4/Picture/5 description: The image shows a circular object against a black background. The object appears to be a light beige or off-white color. It has a slightly raised edge, giving it a layered appearance.

Dentivera™ Milling Disc

The milling discs are machined into partial or full removable denture frames using available dental CAD/CAM systems. The nominal dimensions are 98 mm in diameter and 28 mm thick. This is the size that would fit most of the commercial dental milling machines currently used in dental laboratories.

# 1.7 Indication for Use

The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.

# 1.8 Contraindications

The Dentivera™ Milling Disc is not to be used in full removable dentures or permanent (i.e., cemented or implant retained) crowns, caps, bridges or superstructures.

# 1.9 Comparison to Predicates

The Dentivera™ Milling Disc resin is substantially equivalent to the Paladon 65 denture base resin in its performance and strength for the use in the manufacture of full and partial removable dentures and overdentures. The Paladon 65 denture based resin was cleared under 510(k) Number K901789. Both products are denture base materials used in the manufacture of full and partial removable dentures.

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When the Dentivera™ Milling Disc and the Paladon 65 are formed into the final denture base and frame products, both materials are used in identical ways and are both compliant with ISO 20795-1 for the strength and durability of denture base materials.

| | Predicate Device<br>(Predicate Device) | Dental Solutions<br>Milling Disc<br>(Subject Device) | Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510(k) Number | K901789 | K160498 | N/A |
| Manufacturer | Heraeus Kulzer, LLC<br>300 Heraeus Way<br>South Bend, Indiana<br>46614 | Dental Solutions, LLC.<br>P.O. Box 270725<br>7701 Golden Valley Rd.<br>Golden Valley, MN<br>55427 | N/A |
| Classification | II | II | Same |
| Product Code | EBI | EBI | Same |
| Regulation | 21 CFR 872.3760 | 21 CFR 872.3760 | Same |
| Indications for Use | Paladon 65 is a denture<br>base resin designed for<br>fixed and removable<br>dentures: Full and<br>partial dentures. | The Dentivera™ Milling<br>Disc is a thermoplastic<br>denture base resin<br>designed for the<br>manufacture of full and<br>partial removable<br>dentures and<br>overdentures. | Substantially<br>Equivalent |
| Main Chemical<br>Composition | Polymethyl acrylate;<br>methyl methacrylate,<br>dimethyl acrylate,<br>impact modifier | Arylketone<br>thermoplastic resin | Substantially<br>Equivalent |
| Shelf Life | 5 years | 10 years | Substantially<br>Equivalent |
| Denture Fabrication<br>Method | Mixing and molding of<br>resin into physical<br>mold followed by<br>curing of resin | Pre-molding of resin into<br>rigid disc followed by<br>CAD/CAM milling of<br>denture | Substantially<br>Equivalent |
| Flexural Strength > 65<br>MPa<br>(ISO 20795-1) | Pass | Pass | Substantially<br>Equivalent |
| Flexural Modulus ><br>2000 MPa<br>(ISO 20795-1) | Pass | Pass | Substantially<br>Equivalent |
| Water Sorption ≤ 32<br>ug/mm3<br>(ISO 20795-1) | Pass | Pass | Substantially<br>Equivalent |
| Water Solubility ≤ 1.6<br>ug/mm3<br>(ISO 20795-1) | Pass | Pass | Substantially<br>Equivalent |

# Table 3: Dental Solutions Dentivera™ Milling Disc Substantial Equivalence Table

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As outlined above, the Dental Solutions Denitvera™ Milling Disc resin and the Paladon 65 resin are substantially equivalent is use and both materials physical properties exceed the minimum requirements of ISO 20795-1 for Denture base polymers and resins. The use of the Dentivera™ Milling Disc does not result in any additional risks over and above that of the Paladon 65.

# 1.10Performance Testing

Side-by-side testing of the Dentivera™ Milling Disc resin and the Paladon 65 resins showed that both materials are compliant with the ISO 20795-1 : Dentistry -Base polymers Part 1: Denture base polymers standard relating to mechanical properties of denture base materials. These results are summarized in the Substantial Equivalence table above.

In addition, biocompatibility testing was performed on the Dentivera™ Milling Disc resin in accordance with ISO 10993-1.

| Test | Standard<br>Applied | Relevant Results |
|-------------------------------------------------------------------------------|---------------------|------------------|
| Cytotoxicity<br>MEM Elution Method | ISO 10993-5 | Non-cytotoxic |
| Sensitization<br>Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-10 | Non-irritating |
| Systemic Toxicity Acute<br>Systemic Injection | ISO 10993-11 | Non-toxic |
| 13 Week Subchronic<br>Systemic Toxicity in Rats,<br>Subcutaneous Implantation | ISO 10993-6 | Non-toxic |
| Intramuscular Implantation<br>Study - 4 Week | ISO 10993-6 | Non-irritating |
| Bacterial Reverse Mutation<br>Assay | ISO 10993-3 | Non-mutagenic |
| Genotoxicity: Mouse<br>Peripheral Blood<br>Micronucleus Study | ISO 10993-3 | Non-genotoxic |
| Genotoxicity: Mouse<br>Lymphoma Assay | ISO 10993-3 | Non-genotoxic |
| Pyrogen Test | USP <151> | Non-pyrogenic |

# Table 4: Biocompatibility Testing Summary of Dentivera™ Milling Disc Ultaire™ AKP resin

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| Test | Standard<br>Applied | Relevant Results |
|---------------------------------------------------|--------------------------|------------------|
| Chemical Characterization<br>of PXM-15263 Resin | ISO 10993-18 | Pass |
| Chemical Characterization<br>of PXM-15263 Discs | ISO 10993-18 | Pass |
| Biological Risk Assessment<br>Dental Milling Disc | ISO 10993-1<br>ISO 14071 | Pass |

# 1.11 Conclusion

Dental Solutions LLC considers the Dentivera™ Milling Disc denture base resin to be substantially equivalent to the Paladon 65 denture base resin in that its use and performance as a denture base resin is equivalent to the predicate in terms of chemical characterization, biocompatibility and ISO based performance testing. . This conclusion is based upon the devices' similarities in intended use, design, and mechanical properties.