(113 days)
Not Found
No
The summary describes a material (milling disc) used in a CAD/CAM system, but there is no mention of AI or ML being used in the material itself or the milling process described.
No
The device is a material (resin disc) used to manufacture dentures, not a device that directly interacts with the body for therapeutic purposes.
No
The device description clearly states it is a resin for manufacturing dentures, not for diagnosing medical conditions.
No
The device is a physical milling disc made of thermoplastic resin, not software.
Based on the provided information, the Dentivera™ Milling Disc is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manufacture of full and partial removable dentures and overdentures. This is a device used in the mouth for prosthetic purposes, not for testing samples outside the body to diagnose a condition.
- Device Description: It's a material (thermoplastic resin) that is machined into a physical dental prosthesis.
- Lack of IVD Characteristics: There is no mention of it being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Dentivera™ Milling Disc does not fit this description.
N/A
Intended Use / Indications for Use
The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
Product codes (comma separated list FDA assigned to the subject device)
EBI
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
In addition, biocompatibility testing was performed on the Dentivera™ Milling Disc resin in accordance with ISO 10993-1. Relevant results include:
Cytotoxicity (MEM Elution Method): Non-cytotoxic (ISO 10993-5)
Sensitization (Guinea Pig Maximization): Non-sensitizing (ISO 10993-10)
Intracutaneous Reactivity: Non-irritating (ISO 10993-10)
Systemic Toxicity Acute (Systemic Injection): Non-toxic (ISO 10993-11)
13 Week Subchronic Systemic Toxicity in Rats, Subcutaneous Implantation: Non-toxic (ISO 10993-6)
Intramuscular Implantation Study - 4 Week: Non-irritating (ISO 10993-6)
Bacterial Reverse Mutation Assay: Non-mutagenic (ISO 10993-3)
Genotoxicity: Mouse Peripheral Blood Micronucleus Study: Non-genotoxic (ISO 10993-3)
Genotoxicity: Mouse Lymphoma Assay: Non-genotoxic (ISO 10993-3)
Pyrogen Test: Non-pyrogenic (USP )
Chemical Characterization of PXM-15263 Resin: Pass (ISO 10993-18)
Chemical Characterization of PXM-15263 Discs: Pass (ISO 10993-18)
Biological Risk Assessment Dental Milling Disc: Pass (ISO 10993-1, ISO 14071)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength > 65 MPa (ISO 20795-1): Pass
Flexural Modulus > 2000 MPa (ISO 20795-1): Pass
Water Sorption ≤ 32 ug/mm3 (ISO 20795-1): Pass
Water Solubility ≤ 1.6 ug/mm3 (ISO 20795-1): Pass
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are connected to three flowing ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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: +1-770-772-8649 kmspanda@comcast.net
1.2 Submission Correspondent
Brian J. Edwards Principal Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway Suite 450 Minneapolis, MN 55422 Phone: +1-763-390-8409 Fax: +1-763-287-3836 bedwards@namsa.com
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.
4
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.
5
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
(Predicate Device) | Dental Solutions
Milling Disc
(Subject Device) | Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510(k) Number | K901789 | K160498 | N/A |
| Manufacturer | Heraeus Kulzer, LLC
300 Heraeus Way
South Bend, Indiana
46614 | Dental Solutions, LLC.
P.O. Box 270725
7701 Golden Valley Rd.
Golden Valley, MN
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
base resin designed for
fixed and removable
dentures: Full and
partial dentures. | The Dentivera™ Milling
Disc is a thermoplastic
denture base resin
designed for the
manufacture of full and
partial removable
dentures and
overdentures. | Substantially
Equivalent |
| Main Chemical
Composition | Polymethyl acrylate;
methyl methacrylate,
dimethyl acrylate,
impact modifier | Arylketone
thermoplastic resin | Substantially
Equivalent |
| Shelf Life | 5 years | 10 years | Substantially
Equivalent |
| Denture Fabrication
Method | Mixing and molding of
resin into physical
mold followed by
curing of resin | Pre-molding of resin into
rigid disc followed by
CAD/CAM milling of
denture | Substantially
Equivalent |
| Flexural Strength > 65
MPa
(ISO 20795-1) | Pass | Pass | Substantially
Equivalent |
| Flexural Modulus >
2000 MPa
(ISO 20795-1) | Pass | Pass | Substantially
Equivalent |
| Water Sorption ≤ 32
ug/mm3
(ISO 20795-1) | Pass | Pass | Substantially
Equivalent |
| Water Solubility ≤ 1.6
ug/mm3
(ISO 20795-1) | Pass | Pass | Substantially
Equivalent |
Table 3: Dental Solutions Dentivera™ Milling Disc Substantial Equivalence Table
6
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
Applied | Relevant Results |
|-------------------------------------------------------------------------------|---------------------|------------------|
| Cytotoxicity
MEM Elution Method | ISO 10993-5 | Non-cytotoxic |
| Sensitization
Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-10 | Non-irritating |
| Systemic Toxicity Acute
Systemic Injection | ISO 10993-11 | Non-toxic |
| 13 Week Subchronic
Systemic Toxicity in Rats,
Subcutaneous Implantation | ISO 10993-6 | Non-toxic |
| Intramuscular Implantation
Study - 4 Week | ISO 10993-6 | Non-irritating |
| Bacterial Reverse Mutation
Assay | ISO 10993-3 | Non-mutagenic |
| Genotoxicity: Mouse
Peripheral Blood
Micronucleus Study | ISO 10993-3 | Non-genotoxic |
| Genotoxicity: Mouse
Lymphoma Assay | ISO 10993-3 | Non-genotoxic |
| Pyrogen Test | USP | Non-pyrogenic |
Table 4: Biocompatibility Testing Summary of Dentivera™ Milling Disc Ultaire™ AKP resin
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| Test | Standard
Applied | Relevant Results |
|---------------------------------------------------|--------------------------|------------------|
| Chemical Characterization
of PXM-15263 Resin | ISO 10993-18 | Pass |
| Chemical Characterization
of PXM-15263 Discs | ISO 10993-18 | Pass |
| Biological Risk Assessment
Dental Milling Disc | ISO 10993-1
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.