(88 days)
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads 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 liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting).
While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright).
I am unable to answer most of your questions as this document is a 510(k) summary for a denture base resin, not an AI/ML medical device. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are not applicable.
However, I can provide the following information based on the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by the ISO 20795-1 standard for denture base polymers. The reported device performance is compared against the minimums/maximums set by this standard.
Heat-Cure Acrylics (Basis, Basis HI, Basis Twin Cure):
| Acceptance Criteria (ISO 20795-1) | Reported Device Performance (Subject Devices) | Reported Device Performance (Predicate Devices) |
|---|---|---|
| Flexural Strength: 65 MPa Minimum | Basis: 84.3 MPa; Basis HI: 87 MPa; Basis Twin Cure: 81.0 MPa | Veracril: 70.8 MPa; Veracril HI: 88.1 MPa; Ez-cryl: 70.5 MPa |
| Flexural Modulus: 2,000 MPa Minimum | Basis: 2,067 MPa; Basis HI: 2,178 MPa; Basis Twin Cure: 2,299 MPa | Veracril: 5,300 MPa; Veracril HI: 5,804 MPa; Ez-cryl: 5,700 MPa |
| Impact-Resistance: Min 1.9 MPa m^(1/2) | Basis/Basis TC: Not Applicable; Basis HI: > 2.26 MPa m^(1/2) | Veracril/Ez-cryl: Not Applicable; Veracril High Impact: 3.1 MPa m^(1/2) |
| Residual Monomer: Maximum 2.2% | Basis: 0.4%; Basis HI: 0.7%; Basis Twin Cure: 0.2% | Veracril: 0.98%; Veracril HI: 1.88%; Ez-cryl: 0.80% |
| Sorption: Max 32 ug/mm3 | Basis: 10.7 ug/mm3; Basis HI: 22.8 ug/mm3; Basis Twin Cure: 22.4 ug/mm3 | Veracril: 18.1 ug/mm3; Veracril Hi: 14.5 ug/mm3; Ez-cryl: 19.1 ug/mm3 |
| Solubility: Max 1.6 ug/mm3 | Basis: 0.6 ug/mm3; Basis HI: 0.4 ug/mm3; Basis Twin Cure: 0.2 ug/mm3 | Veracril: 0.8 ug/mm3; Veracril HI: 0.9 ug/mm3; Ez-cryl: 0.72 ug/mm3 |
| Classification (ISO 20795-1:2008): Type 1 Class 1 or Type 5 | Basis & Basis HI: Type 1 Class 1; Basis Twin Cure: Type 5 | Veracril & Veracril HI: Type 1 Class 1; EZ-cryl: Type 5 |
Self-Cure Acrylics (Basis Flow, Re-Fine Bright):
| Acceptance Criteria (ISO 20795-1) | Reported Device Performance (Subject Devices) | Reported Device Performance (Predicate Devices) |
|---|---|---|
| Flexural Strength: 60 MPa Minimum | Basis Flow: 80.1 MPa; Re-Fine Bright: 73.8 MPa | Vertex Self Curing: 68 MPa; Vertex Castavaria: 79MPa |
| Flexural Modulus: 1,500 MPa Minimum | Basis Flow: 1,657 MPa; Re-Fine Bright: 1,529 MPa | Vertex Self Curing: 2,028 MPa; Vertex Castavaria: 2,316 MPa |
| Residual Monomer: Maximum 4.5% | Basis Flow: 4.2%; Re-Fine Bright: 3.3% | Vertex Self Curing: 3.76%; Vertex Castavaria: 3.91% |
| Sorption: Max 32 ug/mm3 | Basis Flow: 18.8 ug/mm3; Re-Fine Bright: 15.8 ug/mm3 | Vertex Self Cure: 20.3 ug/mm3; Vertex Castavaria: 23.2 ug/mm3 |
| Solubility: Max 8.0 ug/mm3 | Basis Flow: 1.8 ug/mm3; Re-Fine Bright: 2.3 ug/mm3 | Vertex Self Cure: 1.8 ug/mm3; Vertex Castavaria: 1.8 ug/mm3 |
| Classification (ISO 20795-1:2008): Type 2 Class 2 or Type 2 Class 1 | Basis Flow: Type 2 Class 2; Re-Fine Bright: Type 2 Class 1 | Vertex SC: Type 2 Class 2; Vertex Castavaria: Type 2 Class 1 |
Summary of Device Performance: The document explicitly states: "All Physical Properties within specification" for both heat-cure and self-cure acrylics, and "All Physical Properties within specification" (duplicate entry) for self-cure acrylics. This indicates that the subject devices (Yamahachi Denture Base Resins) met all the specified acceptance criteria from ISO 20795-1.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each physical property test. It refers to "Bench tests were performed on the subject device in conformity with ISO 20795-1." This standard would dictate the required sample sizes for each test.
- Data Provenance: The device manufacturer is Yamahachi Dental Manufacturing Co. in Japan. The testing was conducted in conformity with ISO 20795-1, which is an international standard. The specific country where the bench tests were performed is not explicitly stated, but it can be inferred to be associated with the manufacturer or a certified testing facility accredited to ISO standards. The tests are non-clinical bench tests, not clinical studies, so the terms "retrospective or prospective" do not directly apply in the same way they would for patient data. These are laboratory measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The "ground truth" for the performance of these materials is established by the ISO 20795-1 standard, which defines standardized test methods and acceptance values for physical and chemical properties of denture base polymers. These are objective measurements determined in a laboratory setting, not subjective interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews where there is subjective assessment or disagreement amongst human readers. The tests performed are objective, standardized physical property measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This device is a denture base resin, not an AI-powered diagnostic or assistive medical device. No human readers or AI assistance are involved in its intended use or performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical material (resin), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance criteria is defined by the ISO 20795-1 international standard for denture base polymers. This standard specifies scientifically validated benchmarks and test methodologies for physical properties like flexural strength, flexural modulus, impact resistance, residual monomer, sorption, and solubility. These are objective, measurable physical and chemical properties, not subjective assessments.
8. The sample size for the training set
This question is not applicable. This device is a physical material, not an AI/ML model that requires a training set. The term "training set" is relevant to machine learning, not the testing of physical properties of denture resins.
9. How the ground truth for the training set was established
This question is not applicable for the reasons mentioned in point 8.
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510(k) Summary
510(k) Owner
JUL 1 2 2013
Yamahachi Dental Manufacturing Co. 54-1 Ochigara, Nishiura-Cho Gamagori City, Aichi Pref., Japan 443-0105
| Phone: | 081-533-577121 |
|---|---|
| Fax: | 081-533-5771764 |
| Contact: | Lawrence Greenwald (yamahachi1@yahoo.com) |
Date Prepared
April 1, 2013
Consultant
Denterprise International, Inc. 110 E. Granada Blvd., Suite 207 Ormond Beach, FL 32176
| Phone: | 386-672-0450 |
|---|---|
| Fax: | 386-672-4402 |
| Primary Contact: | Claude Berthoin, President (claude@510kfda.com) |
| Secondary Contact: | John Gillespy, VP Regulatory Affairs (john@510kfda)Holly Layne, Assistant (holly@510kfda) |
Device Classification
| 510(k) Name: | Yamahachi Denture Base Resins |
|---|---|
| Trade/Model Names: | Basis, Basis HI, Basis Twin Cure, Basis Flow, Re-Fine Bright |
| Common Name: | Denture Base Polymer |
| Classification Name: | Denture Relining, Repairing, or Rebasing Resin |
| Regulation Number: | 872.3760 |
| Product Code: | EBI |
| Regulatory Class: | II |
Predicates
| K102874 | Veracril, Veracril HI, Ez-Cryl (New Stetic, Columbia) |
|---|---|
| K102640 | Vertex Self-Curing, Vertex Castavaria (Vertex Dental, The Netherlands) |
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Intended Use
Yamahachi Denture Base Resins is a system of heat- and self-cure acrylic polymers intended for fabrication or repair of the denture base.
Device Description
Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads 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 liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting).
While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright).
Device Comparison To Predicates
A comparison of technological characteristics between the subject and predicate devices follows in Tables 5A and 5B ...
Table 5A -- Comparison Of Heat-Cure Acrylics
| Subject Devices | Predicate Devices | Differences | |
|---|---|---|---|
| Device Names | Basis, Basis HI,Basis Twin Cure | Veracril, Veracril HI,EZ-cryl | NA |
| Manufacturer | Yamahachi Dental (Japan) | New Stetic (Columbia) | NA |
| 510(k) | Not assigned yet | K102874 (Bundle of 5 Heat-Curing& 3 Self-Curing) | NA |
| Classification &Product Code | 872.3760; EBI | 872.3760; EBI | NA |
| Device Description | Traditional heat-cure µwave-cure acrylicresin for total or partialdenture base and forremovable prosthesis | Denture system consisting ofmonomer and polymer powder andliquid components (traditionalheat-cured & microwave-curedacrylic resin for total or partialdenture base and for removableprosthesis) | No difference inDevice Description orIntended Use |
| Intended Use | Repair or fabrication of denture base | Repair or fabrication of denture base | |
| Product State | Polymer powder &monomer liquid | Polymer powder & monomer liquid | |
| Mixing Ratio(Powder:Liquid) | 100g:43ml (Basis & BasisHI); 100g:40ml (Basis TwinCure) | 2:1 by weight or 3:1 by volume | The only difference in |
| Mixing Time | 30 sec | 30 sec | Method Of Use is |
| Pressing Technique | Pack dough in plastermodel, apply pressure, trimexcess, apply final pressure(10 - 15 minute packingtime) | Pack dough in flask, apply pressure,trim excess, apply final pressure | determination ofmixing ratio. Thisdifference is related tocharacteristics ofpolymer particle size,but does not affect |
| Application Time | 30 minutes | Approx 10 minutes | |
| Polymerization(Curing) Method | Water Bath: Immerse flaskin water & slowly raise toboiling over 30 min, boil 30- 40 min, air cool 30 min(Basis & Basis HI); RapidCuring: Immerse flask inboiling water 30 min (BasisTC); Microwave: Put flaskin MWO 500W for 3 min,air cool 30 min (Basis TC) | Water Bath: 90 min at 73° C, 30min boiling, 30 min air cool, 15 minwater cool (Veracril devices);Microwave: 10 min in 3 stages inMWO, air cool 30 min, 15 minwater cool (EZ-cryl only) | performance of devicenor raise issues ofsafety or effectiveness,a conclusionsupported by meetingrequirements ofstandard ISO 20795-1. |
| Components (Seelegend after table) | Powder: PMMA, MMA(Basis Hi), initiator,pigments;Liquid: MMA, crosslinker,activator (Basis TC) | Powder: PMMA, pigments;Liquid: MMA, crosslinker | The only difference inProduct Componentsare minor variances inpercentages ofingredients, which donot affect productperformance, safety,or effectiveness, assupported by meetingthe standards of ISO20795-1. |
| Standards ofConformity | ISP 9001:2008; ISO13485:2003; MDD(93/42/EEC); ISO 14971 | ISP 9001:2008; ISO 13485:2003 | |
| Biocompatibility | ISO 10993-1, ISO 7405 | ISO 10993-1, ISO 7405 | |
| Physical Properties | ISO 20795-1 | ANSI/ADA 12:2002; ISO 1567:1999 | |
| Flexural Strength(65 MPa Minimum) | Basis: 84.3 MPa;Basis HI: 87 MPa;Basis Twin Cure: 81.0 MPa | Veracril: 70.8 MPa;Veracril HI: 88.1 MPa;Ez-cryl: 70.5 MPa | All Physical Propertieswithin specification |
| Flexural Modulus(2,000 MPa Min) | Basis: 2,067 MPa;Basis HI: 2,178 MPa;Basis Twin Cure: 2,299 MPa | Veracril: 5,300 MPa;Veracril HI: 5,804 MPa;Ez-cryl: 5,700 MPa | |
| Impact-Resistance(Min 1.9 MPa m1/2) | Basis/Basis TC: NotApplicable;Basis HI: >$2.26 MPa m^{1/2}$ | Veracril/Ez-cryl: Not Applicable;Veracril High Impact: $3.1 MPa m^{1/2}$ | |
| Residual Monomer(Maximum 2.2%) | Basis: 0.4%;Basis HI: 0.7%;Basis Twin Cure: 0.2% | Veracril: 0.98%;Veracril HI: 1.88%;Ez-cryl: 0.80% | |
| Sorption(Max 32 ug/mm3) | Basis: 10.7 ug/mm3;Basis HI: 22.8 ug/mm3;Basis Twin Cure: 22.4 ug/mm3 | Veracril: 18.1 ug/mm3;Veracril Hi: 14.5 ug/mm3;Ez-cryl: 19.1 ug/mm3 | |
| Solubility(Max 1.6 ug/mm3) | Basis: 0.6 ug/mm3;Basis HI: 0.4 ug/mm3;Basis Twin Cure: 0.2 ug/mm3 | Veracril: 0.8 ug/mm3;Veracril HI: 0.9 ug/mm3;Ez-cryl: 0.72 ug/mm3 | |
| Classification(ISO 20795-1:2008) | Basis & Basis HI: Type 1 Class 1;Basis Twin Cure: Type 5 | Veracril & Veracril HI: Type 1 Class 1;EZ-cryl: Type 5 | No Classificationdifference |
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・
.
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MMA - Methyl-methacrylate PMMA - Poly-methyl-methacrylate
PEMA - 2-(N-pyrolyl) ethyl methacrylate
Table 5B -- Comparison Of Self-Cure Acrylics
| Subject Devices | Predicate Devices | Differences | |
|---|---|---|---|
| Device Names | Basis Flow,Re-Fine Bright | Vertex Self Curing,Vertex Castavaria | NA |
| Manufacturer | Yamahachi Dental (Japan) | Vertex-Dental (Netherlands) | NA |
| 510(k) | Not assigned yet | K102640 (Bundle of 3 Self-Curing Resins) | NA |
| Classification &Product Code | 872.3760; EBI | 872.3760; EBI | |
| Device Description | Basis Flow: Self-curingdenture base materialintended as a pouring andrepair acrylic.Re-fine Bright: Multifunctionalself-polymerizing denturebase material for repair andrelining of full & partialdentures | Vertex Self Curing: Self-curingdenture base materialintended as a pouring andrepair acrylic.Vertex Castavaria:Multifunctional self-polymerizing denture basematerial for repair andrelining of full & partialdentures | No difference in DeviceDescription or IntendedUse |
| Intended Use | Repair and relining of full &partial dentures | Fabrication, repair andrelining of full & partialdentures |
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| Product State | Polymer powder & monomerliquid | Polymer powder & monomerliquid | The only difference inMethod Of Use iscuring method for Re-Fine Bright, which is notpressure cured. Thisdifference does notaffect performance ofdevice, safety, oreffectiveness, assupported by meetingrequirements ofstandard ISO 20795-1. |
|---|---|---|---|
| Mixing Ratio(Powder:Liquid) | 100 g : 50 - 60 ml | 100 g : 60 ml | |
| Mixing Time | 5 - 30 sec | 20 sec | |
| Dough Time | Max 3 min | Max 4.5 - 8 min | |
| Working Time | Max 4 min | Max 5 - 8 min | |
| Polymerization(Curing) Method | Basis Flow: 30 min at 55° C in0.2 atm pressure vessel, aircool 30 min;Re-Fine Bright: Let hardpolymerize | Vertex Self Curing: 10 min at55° C in 2.5 bar pressurevessel;Vertex Castavaria: 30 min at55° C in 2.5 bar pressurevessel | |
| Components (Seelegend beforetable) | Powder: PMMA, PEMA,activators, pigments;Liquid (Basis Flow): MMA,crosslinker, activator;Liquid (Re-fine Bright): MMA,crosslinker, activators | Powder: PMMA 99.1%,Inhibitor (dibenzoyl peroxide)<1%;Liquid: MMA >95%,Crosslinker <5%, Accelerators<1%, UV Absorber << 1% | The only difference inProduct Componentsare minor variances inpercentages ofingredients, which donot affect productperformance, safety, oreffectiveness, assupported by meetingthe standards of ISO20795-1. |
| Standards ofConformity | ISP 9001:2008; ISO13485:2003; MDD(93/42/EEC); ISO 14971 | ISO 1567, ISO 179-1, ASTIM F895-84 | |
| Biocompatibility | ISO 10993-1, ISO 7405 | ISO 7405 | |
| Physical Properties | ISO 20795-1 | ISO 20795-1 | |
| Flexural Strength(60 MPa Minimum) | Basis Flow: 80.1 MPa;Re-Fine Bright: 73.8 MPa | Vertex Self Curing: 68 MPa;Vertex Castavaria: 79MPa | |
| Flexural Modulus(1,500 MPa Min) | Basis Flow: 1,657 MPa;Re-Fine Bright: 1,529 MPa | Vertex Self Curing: 2,028 MPa;Vertex Castavaria: 2,316 MPa | All Physical Propertieswithin specification |
| Residual Monomer(Maximum 4.5%) | Basis Flow: 4.2%;Re-Fine Bright: 3.3% | Vertex Self Curing: 3.76%;Vertex Castavaria: 3.91% | |
| Sorption(Max 32 ug/mm3) | Basis Flow: 18.8 ug/mm3;Re-Fine Bright: 15.8 ug/mm3 | Vertex Self Cure: 20.3 ug/mm3; VertexCastavaria: 23.2 ug/mm3 | |
| Solubility(Max 8.0 ug/mm3) | Basis Flow: 1.8 ug/mm3;Re-Fine Bright: 2.3 ug/mm3 | Vertex Self Cure: 1.8 ug/mm3;Vertex Castavaria: 1.8 ug/mm3 | |
| Classification(ISO 20795-1:2008) | Basis Flow: Type 2 Class 2;Re-Fine Bright: Type 2 Class 1 | Vertex SC: Type 2 Class 2;Vertex Castavaria: Type 2Class 1 | No Classificationdifference |
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Non-Clinical Tests
Bench tests were performed on the subject device in conformity with ISO 20795-1. These tests confirmed the different resins (Basis, Basis Twin Cure, Basis Flow, and Re-Fine Bright) all met the performance criteria established by that standard.
Substantial Equivalence Discussion
As noted above ...
- Product Description and Intended Use are the same for the subject and predicate . devices.
- . The only difference in Method Of Use is determination of mixing ratio. This difference is related to characteristics of polymer particle size, but does not affect performance of device nor raise issues of safety or effectiveness, a conclusion supported by meeting requirements of standard ISO 20795-1.
- The only difference in Product Components are minor variances in percentages of . ingredients, which do not affect product performance, safety, or effectiveness, as supported by meeting the standards of ISO 20795-1.
- . The Physical Properties of both the subject and predicate devices conform to the standards of ISO 20795-1.
- Classification of the dental acrylic resins is the same between subject and predicate . devices.
Yamahachi Denture Base Resins has the same intended use as the predicates. The subject device also has minor differences in technological characteristics that could not affect safety or effectiveness. Bench tests show conformance with performance standards in ISO 20795-1:2008 for all five models included in this submission (Basis, Basis HI, Basis Twin Cure, Basis Flow, and Re-fine Bright).
In conclusion, Yamahachi Denture Base Resins warrants a finding of substantial equivalence to legally marketed devices from New Stetic (Columbia) and Vertex Dental (The Netherlands) and of proper clearance for premarketing activities in the United States.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing segments and three wave-like lines below, possibly representing water or movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2013
Yamahachi Dental Manufacturing Co. C/O Mr. Claude Berthoin, President Denterprise International, Inc. 110 E. Granada Boulevard, Suite 207 Ormond Beach, FL 32176
Re: K131036
Trade/Device Name: Yamahachi Denture Base Resins Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Repairing Resin Regulatory Class: II Product Code: EBI Dated: April 26, 2013 Received: April 29, 2013
Dear Mr. Berthoin:
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. Berthoin
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 (800) 638-2041 or (301) 796-7100 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/7/Picture/6 description: The image shows the text "Mary S. Runner -S". The text is written in a clear, bold font, making it easily readable. The letters are black, contrasting with the white background.
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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Indications For Use Statement
Applicant: Yamahachi Dental Manufacturing Co.
| 510(k) Number (if known): | K131636 |
|---|---|
| --------------------------- | --------- |
Device Name: Yamahachi Denture Base Resins
Indications For Use:
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
All devices are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
Prescription Use _X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division Sign-Off Office of Device Evaluation
510(k)
(Division Sign-Off) (Division Sign-Off)
Division of Anesthealogy, General Hospital Division of Antost Dental Devices
510(k) Number: K131036
§ 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.