(90 days)
Not Found
No
The device description details a chemical process for fabricating denture bases using PMMA and MMA, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on material properties according to ISO standards.
No
The device is a material used for fabricating or repairing denture bases, not a device that directly interacts with the body to achieve a therapeutic effect.
No
The intended use of the device is for the fabrication or repair of denture bases, which is a therapeutic or restorative purpose, not a diagnostic one.
No
The device description clearly states the device is supplied as components in powder and liquid form, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication or repair of the denture base." This is a dental material used to create a physical prosthetic.
- Device Description: The description details the chemical composition and the process of mixing and curing the material to form a denture base. This is a manufacturing process for a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BASIS FLOW II does not perform any such function.
N/A
Intended Use / Indications for Use
The BASIS FLOW II is intended for fabrication or repair of the denture base.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
BASIS FLOW II is supplied as components in powder and liguid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.
To fabricate the denture base, the powder and liguid materials are mixed and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).
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)
Basis FLOW II was tested in accordance with ISO 20795-1:2013 Dentistry - Base Polymers -Part 1: Denture Base polymers (Type 2, Class 2) and ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic base polymers (Type 1).
The subject device and predicate device have similar levels of flexural strength, flexural modulus, residual monomer, sorption, and solubility. Both meet ISO standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: 92.5 MPa
Flexural Modulus: 3,310 MPa
Residual Monomer: 3.4%
Sorption: 24.5 µg/mm3
Solubility: 0.7 µg/mm3
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2024
Yamahachi Dental MFG., Co. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St. Suite 200 Gardena, California 90248
Re: K233859
Trade/Device Name: BASIS FLOW II Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: December 5, 2023 Received: December 6, 2023
Dear Takahiro Haruyama:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233859
Device Name BASIS FLOW II
Indications for Use (Describe) The BASIS FLOW II is intended for fabrication or repair of the denture base.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for YAMAHACHI DENTAL MFG. The logo includes the company name in bold, black letters. Below the company name, it states that they are manufacturers and importers.
PORTERS OF DENTAL PRODUC
54-1 OCHIGARA, NISHIURA-CHO GAMAGORI-CITY,AICHI-PREF.,JAPAN 443-0105 TEL: ++81-533-57-7121 FAX:++81-533-57-1764 URL:http://www.yamahachi-dental.co.jp/ E-mail:box@yamahachi-dental.co.jp
510(k) Summary
510(k) #: K233859
Prepared on 2024-03-01
CONTACT DETAILS:
Applicant Name: YAMAHACHI DENTAL MFG., Co. Applicant Address: 54 -1 Ochigara, Nishiura-Cho Gamagori-City, Aichi-Pref. 443-0105 Japan Applicant Contact Telephone: +81-533-57- 7121 Applicant Contact: Shuhei Hirota Applicant Contact Email: hirota@yamahachi -dental.co.jp
Device Name
Device Trade Name: BASIS FLOW II Common Name: Dental Resin Classification Name: EBI. Denture Relining, Repairing, Rebasing Resin. Regulation Number: 872.3760
Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K131036 | ||
| (Primary predicate) | Yamahachi Denture Base Resins -Basis FLOW | EBI |
5
AMAHACHI DENTAL MFG. CO MANUFACTURERS, IMPORTERS A EXPORTERS OF DENTAL PRODU
1. Device Description
BASIS FLOW II is supplied as components in powder and liguid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.
To fabricate the denture base, the powder and liguid materials are mixed and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).
2. Indications for Use
The BASIS FLOW II is intended for fabrication or repair of the denture base.
3. Technological Comparison
| Subject Device | Predicate Device | Differences | |
|---|---|---|---|
| Device Name | Basis FLOW II | Basis FLOW | |
| 510(k) number | K233859 | K131036 | |
| Manufacturer | Yamahachi Dental | Yamahachi Dental | |
| Regulation | 872.3760 | 872.3760 | Same |
| Product Code | EBI | EBI | Same |
| Device | |||
| Description | Self-curing denture base material | ||
| intended as a pouring acrylic. | Self-curing denture base material | ||
| intended as a pouring acrylic. | Same | ||
| Intended Use | Materials for the gum portion of | ||
| dentures. It may be used as a | |||
| material for the plate portion of | |||
| orthodontic appliances. | Materials for the gum portion of | ||
| dentures. It may be used as a | |||
| material for the plate portion of | |||
| orthodontic appliances. | Same | ||
| Product State | Polymer powder & monomer | ||
| liquid | Polymer powder & monomer | ||
| liquid | Same | ||
| Flexural | |||
| Strength | 92.5 MPa | 80.1 MPa | Similar |
| Flexural | |||
| Modulus | 3,310 MPa | 1,657 MPa | Similar |
| Residual | |||
| Monomer | 3.4% | 4.2% | Similar |
| Sorption | 24.5 µg/mm3 | 18.8 µg/mm³ | Similar |
| Solubility | 0.7 µg/mm3 | 1.8 µg/mm³ | Similar |
Page 2 of 4
6
Image /page/6/Picture/0 description: The image shows the logo for Yamahachi Dental MFG, CO. The logo includes a stylized tooth graphic with the word "YAMAHACHI" inside. Below the logo, the text reads "MANUFACTURERS, IMPORTERS AND EXPORTERS OF DENTAL PRODUCTS".
4. Nonclinical Performance Data
Basis FLOW II was tested in accordance with ISO 20795-1:2013 Dentistry - Base Polymers -Part 1: Denture Base polymers (Type 2, Class 2) and ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic base polymers (Type 1).
The subject device and predicate device have similar levels of flexural strength, flexural modulus, residual monomer, sorption, and solubility. Both meet ISO standards.
5. Substantial Equivalence Summary / Conclusion
BASIS FLOW II has the same intended use and the same technological characteristics as the predicate device. The only difference is the addition of one inqredient (polymerization inhibitor) to the product components. This addition does not affect product performance, safety, or effectiveness, as supported by meeting the standards of ISO 20795-1.
In conclusion, BASIS FLOW II warrants a finding of substantial equivalence to the legally marketed device BASIS FLOW, one of the bundled devices of Yamahachi Denture Base Resins (K131036), and of proper clearance for premarketing activities in the United States.
7
MAHACHI DENTAL MFG.
ANUFACTURERS, IMPORTERS AND KPORTERS OF DENTAL PRODUC
54-1 OCHIGARA, NISHIURA-CHO GAMAGORI-CITY,AICHI-PREF.,JAPAN 443-0105 TEL: ++81-533-57-7121 FAX:++81-533-57-1764 URL:http://www.yamahachi-dental.co.jp/ E-mail:box@yamahachi-dental.co.jp
Appendix: The Configurations and colors of the subject device, BASIS FLOW II
BASIS FLOW II (Powder, 40G, LF PINK) BASIS FLOW II (Powder, 40G, CLEAR) BASIS FLOW II (Powder, 40G, LF a) BASIS FLOW II (Powder, 40G, V PINK) BASIS FLOW II (Powder, 40G, O PINK) BASIS FLOW II (Powder, 500G, LF PINK) BASIS FLOW II (Powder, 500G, CLEAR) BASIS FLOW II (Powder, 500G, LF a) BASIS FLOW II (Powder, 500G, V PINK) BASIS FLOW II (Power, 500G, O PINK) BASIS FLOW II (Powder, 10KG, LF PINK) BASIS FLOW II (Powder, 10KG, CLEAR) BASIS FLOW II (Powder, 10KG, LF α) BASIS FLOW II (Power, 10KG, V PINK) BASIS FLOW II (Powder, 10KG, O PINK) BASIS FLOW II (Liquid, 25ML) BASIS FLOW II (Liquid, 500ML) BASIS FLOW II (Liquid, 4L) BASIS FLOW II (Liquid, 17L) BASIS FLOW II (Powder + Liguid set, 40G* 25ML, LF PINK) BASIS FLOW II (Powder + Liquid set, 40G25ML, CLEAR) BASIS FLOW II (Powder + Liquid set. 40G25ML. LF a) BASIS FLOW II (Powder + Liquid set, 40G25ML, V PINK) BASIS FLOW II (Powder + Liquid set, 40G25ML, O PINK) BASIS FLOW II (Powder + Liquid set, 650G500ML, LF PINK) BASIS FLOW II (Powder + Liquid set, 650G500ML, CLEAR) BASIS FLOW II (Powder + Liquid set, 650G500ML, LF a) BASIS FLOW II (Powder + Liquid set, 650G500ML, V PINK) BASIS FLOW II (Powder + Liquid set, 650G*500ML, O PINK)