(80 days)
Not Found
No
The device description details a conventional heat-cured denture base material and its processing method, with no mention of AI or ML.
No
The device is a material used for fabricating dental prosthetics (dentures), not a therapeutic device that directly treats a medical condition. Its function is restorative (to replace missing teeth), not therapeutic.
No
The device is described as a material for fabricating dentures (full and partial) and is a conventional, heat-cured denture base material. Its intended use is for actual fabrication, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a "conventional dough pack heat cured denture base material" consisting of polymethyl methacrylate powder and methyl methacrylate monomer, which are physical materials, 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 of full and partial dentures. This is a manufacturing process for a medical device (dentures), not a diagnostic test performed on a biological sample to provide information about a patient's health.
- Device Description: The device is a material (polymethyl methacrylate powder and methyl methacrylate monomer) used to create dentures. It's a raw material for fabrication, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Vertex Rapid Simplified is indicated for:
- Fabrication of full dentures
- Fabrication of partial dentures
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.
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)
Comparison of Physical Properties:
Charpy impact strength:
Vertex: 11.3 kj/m²
Probase Hot: 1.36 kj/m²± 0.09
Major.Base 20: 1.36 kj/m²±0.03
flexural strength:
Vertex: 85 MPa
Probase Hot: 87.4 ± 8.9 (MPa)
Major.Base 20: 78 MPa
flexural modulus:
Vertex: 2367 MPa
Probase Hot: 2904.9 ± 281.4 (MPa)
Major.Base 20: 2390 MPa
water absorption:
Vertex: 22.5 microgram/mm³
Probase Hot: Not provided
Major.Base 20: 22.0 microgram/mm³
water solubility:
Vertex: 0.11 microgram/mm³
Probase Hot: Not provided
Major.Base 20: 1.5 microgram/mm³
Residual monomer:
Vertex: 1.33 ± 0.16%
Probase Hot:
§ 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
Submitter: Vertex Dental B.V. Vertex hot-curing denture base material Premarket Notification: Traditional 510(k)
K102654
510(k) Summary
| Submitter Name:
| Submitter Address: | Vertex Dental B.V. |
|---|---|
| Phone Number: | 603 369 3550 |
| Fax Number: | 603 369 3562 |
| DEC - 3 2010 | |
| Contact Person: | William Greenrose |
| Date Prepared: | August 9, 2010 |
| Device Trade Name: | Vertex Rapid Simplified |
| Common Name | Denture base material |
| Classification Name, | |
| Number & | |
| Product Code: | resin, denture, relining, repairing, rebasing |
| 872.3760 | |
| EBI | |
| Predicate Devices: | Probase Hot (K913655), Major.Base 20 (K081884) |
| Device Description | |
| and Statement of | |
| Intended Use | Device Description: The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades. |
| Intended Use: | |
| The Vertex Rapid Simplified is indicated for: |
- Fabrication of full dentures |
- in -Pabrication of full Gentures
:
:
:
·
・
ت
100 million and
・
. 1994 .. :
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1
| Submitter:
Vertex Dental B.V. | Vertex hot-curing denture base material
Premarket Notification: Traditional 510(k) | Feature | Vertex hot-curing
denture base material | Probase Hot | Major.Base 20 | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Summary of
Technological
Characteristics | All of the components found in Vertex™ hot-curing denture base
materials have been used in leqally marketed devices and were found
safe for dental use. | 510(k) Number | Not yet assigned | K913655 | K081884 | |
| Substantial
Equivalence | The Vertex hot-curing denture base material is substantially equivalent
to the Probase Hot (K913655) and Major Base 20 (K081884), with
respect to mode of action and intended use. It is substantially equivalent
to the Probase Cold (K913655) and Major.Base 20 (K081884) denture
base materials, with respect to material of composition. The submitted
device pose the same types of questions about safety or effectiveness
as the existing device. | | Manufacturer | Vertex Dental B.V. | Ivoclar North America, Inc. | Major Prodotti Dentari S.p.a |
| Conclusion | The information discussed above demonstrates that the Vertex hot-
curing denture base material is substantially equivalent to the predicate
devices. | | Classification #
& Product
Code | 872.3760
EBI | 872.3760
EBI | 872.3760
EBI |
| Declarations | This summary includes only information that is also covered in the
0
body of the 510(k).
This summary does not contain any puffery or unsubstantiated
0
labeling claims.
This summary does not contain any raw data, i.e., contains only
0
summary data.
This summary does not contain any trade secret or confidential
0
commercial·information.
This summary does not contain any patient identification information.
০ | Indications for
Use | The Vertex Rapid
Simplified is indicated for:
3. Fabrication of full
dentures
4. Fabrication of
partial dentures | Partial and combination
dentures, conventional
or implant supported
Complete dentures
Hybrid dentures
Relines of conventional
or implant dentures | Major.Base 20 is a denture
base polymer for dental
prosthesis. Poly-
methylmethacrylate based.
Heat-processed polymer.
Powder and liquid.
It is used for:
Dental prosthesis
Partial prosthesis
Clasp prosthesis | |
| Composition of
Materials | Powder:
Polymethyl methacrylate,
Benzoyl peroxide,
Pigments
Liquid:
Methyl methacrylate,
Ethyleneglycol
dimethacrylate, N,N-
dimethyl-4-toluidine,
Tinuvin P | Powder:
Polymethyl
methacrylate, softening
agent, benzoyl
peroxide, pigments
Liquid:
Methyl methacrylate,
dimethacrylate (linking
agent), catalyst | Powder:
Poly-methylmethacrylate,
Pigments
Liquid:
Methyl methacrylate,
Ethyleneglycol
dimethacrylate, N,N-
dimethyl-p-toluidine,
Benzophenone-3 | | | |
| Physical
Properties | Charpy impact strength:
11.3 kj/m²
flexural strength: 85 MPa
flexural modulus: 2367
MPa
water absorption: 22.5
µg/mm³
water solubility: 0.11
µg/mm³
Residual monomer: 1.33 ±
0.16% | Charpy impact strength:
1.36 kj/m²± 0.09
flexural strength 87.4 ±
8.9 (MPa)
flexural modulus 2904.9
± 281.4 (MPa)
Residual monomer: