(88 days)
Not Found
No
The device description focuses on the chemical composition and curing process of denture base resins, with no mention of AI or ML technologies.
No
The device is a material used for fabricating or repairing denture bases, which are prosthetic components, not devices intended for treating or diagnosing medical conditions.
No
The device is a material (resin) used for the fabrication and repair of denture bases, which is a manufacturing process, not a diagnostic one.
No
The device description clearly states the device is supplied in powder and liquid form, consisting of chemical components (polymethyl methacrylate, methyl methacrylate, etc.) used to fabricate or repair denture bases. This is a physical material, not software.
Based on the provided information, 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 mechanical and structural application, not a diagnostic test performed on biological samples.
- Device Description: The description details the chemical composition and curing process of the resin materials used to create a physical object (a denture base). It does not describe any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a material used in the manufacturing and repair of dental prosthetics, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
Product codes
EBI
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).
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
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.
Key Metrics
Flexural Strength (65 MPa Minimum)
Basis: 84.3 MPa; Basis HI: 87 MPa; Basis Twin Cure: 81.0 MPa
Flexural Modulus (2,000 MPa Min)
Basis: 2,067 MPa; Basis HI: 2,178 MPa; Basis Twin Cure: 2,299 MPa
Impact-Resistance (Min 1.9 MPa m1/2)
Basis/Basis TC: Not Applicable; Basis HI: > 2.26 MPa m^1/2
Residual Monomer (Maximum 2.2%)
Basis: 0.4%; Basis HI: 0.7%; Basis Twin Cure: 0.2%
Sorption (Max 32 ug/mm3)
Basis: 10.7 ug/mm3; Basis HI: 22.8 ug/mm3; Basis Twin Cure: 22.4 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
Flexural Strength (60 MPa Minimum)
Basis Flow: 80.1 MPa; Re-Fine Bright: 73.8 MPa
Flexural Modulus (1,500 MPa Min)
Basis Flow: 1,657 MPa; Re-Fine Bright: 1,529 MPa
Residual Monomer (Maximum 4.5%)
Basis Flow: 4.2%; Re-Fine Bright: 3.3%
Sorption (Max 32 ug/mm3)
Basis Flow: 18.8 ug/mm3; Re-Fine Bright: 15.8 ug/mm3
Solubility (Max 8.0 ug/mm3)
Basis Flow: 1.8 ug/mm3; Re-Fine Bright: 2.3 ug/mm3
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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) |
1
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 & | ||
| microwave-cure acrylic | |||
| resin for total or partial | |||
| denture base and for | |||
| removable prosthesis | Denture system consisting of | ||
| monomer and polymer powder and | |||
| liquid components (traditional | |||
| heat-cured & microwave-cured | |||
| acrylic resin for total or partial | |||
| denture base and for removable | |||
| prosthesis) | No difference in | ||
| Device Description or | |||
| Intended 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 & Basis | ||
| HI); 100g:40ml (Basis Twin | |||
| Cure) | 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 plaster | ||
| model, apply pressure, trim | |||
| excess, apply final pressure | |||
| (10 - 15 minute packing | |||
| time) | Pack dough in flask, apply pressure, | ||
| trim excess, apply final pressure | determination of | ||
| mixing ratio. This | |||
| difference is related to | |||
| characteristics of | |||
| polymer particle size, | |||
| but does not affect | |||
| Application Time | 30 minutes | Approx 10 minutes | |
| Polymerization | |||
| (Curing) Method | Water Bath: Immerse flask | ||
| in water & slowly raise to | |||
| boiling over 30 min, boil 30 |
- 40 min, air cool 30 min
(Basis & Basis HI); Rapid
Curing: Immerse flask in
boiling water 30 min (Basis
TC); Microwave: Put flask
in MWO 500W for 3 min,
air cool 30 min (Basis TC) | Water Bath: 90 min at 73° C, 30
min boiling, 30 min air cool, 15 min
water cool (Veracril devices);
Microwave: 10 min in 3 stages in
MWO, air cool 30 min, 15 min
water cool (EZ-cryl only) | performance of device
nor raise issues of
safety or effectiveness,
a conclusion
supported by meeting
requirements of
standard ISO 20795-1. |
| Components (See
legend after table) | Powder: PMMA, MMA
(Basis Hi), initiator,
pigments;
Liquid: MMA, crosslinker,
activator (Basis TC) | Powder: PMMA, pigments;
Liquid: MMA, crosslinker | 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. |
| Standards of
Conformity | ISP 9001:2008; ISO
13485:2003; 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 Properties
within 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: 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) | Basis & Basis HI: Type 1 Class 1;
Basis Twin Cure: Type 5 | Veracril & Veracril HI: Type 1 Class 1;
EZ-cryl: Type 5 | No Classification
difference |
2
・
.
3
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-curing | ||
| denture base material | |||
| intended as a pouring and | |||
| repair acrylic. | |||
| Re-fine Bright: Multifunctional | |||
| self-polymerizing denture | |||
| base material for repair and | |||
| relining of full & partial | |||
| dentures | Vertex Self Curing: Self-curing | ||
| denture base material | |||
| intended as a pouring and | |||
| repair acrylic. | |||
| Vertex Castavaria: | |||
| Multifunctional self- | |||
| polymerizing denture base | |||
| material for repair and | |||
| relining of full & partial | |||
| dentures | No difference in Device | ||
| Description or Intended | |||
| Use | |||
| Intended Use | Repair and relining of full & | ||
| partial dentures | Fabrication, repair and | ||
| relining of full & partial | |||
| dentures |
4
| Product State | Polymer powder & monomer
liquid | Polymer powder & monomer
liquid | The only difference in
Method Of Use is
curing method for Re-
Fine Bright, which is not
pressure cured. This
difference does not
affect performance of
device, safety, or
effectiveness, as
supported by meeting
requirements of
standard 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 in
0.2 atm pressure vessel, air
cool 30 min;
Re-Fine Bright: Let hard
polymerize | Vertex Self Curing: 10 min at
55° C in 2.5 bar pressure
vessel;
Vertex Castavaria: 30 min at
55° C in 2.5 bar pressure
vessel | |
| Components (See
legend before
table) | 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)
95%,
Crosslinker