(192 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of the denture base materials, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a denture base material used for the manufacture, repair, rebasing, and relining of dentures, not for treating a disease or condition.
No.
The device is described as a cold-curing denture base material used for the manufacture, repair, rebasing, and relining of dentures, which are restorative functions, not diagnostic ones.
No
The device description clearly states it is a material (polymethyl methacrylate powder and liquid) used for manufacturing, repairing, rebasing, and relining dentures, which are physical objects. It is 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 manufacture, repair, rebasing, and relining of full and partial dentures. This is a mechanical and structural application within the mouth, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is a self-curing acrylic material used to create or modify dentures. It's a physical material, not a reagent, instrument, or system used for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device's function is entirely related to the physical creation and maintenance of dental prosthetics.
N/A
Intended Use / Indications for Use
Vertex cold-curing denture base materials are indicated for:
-
- Manufacture of full and partial dentures
-
- Repair of full and partial dentures
- Rebasing of full and partial dentures 3.
- Relining of full and partial dentures
Vertex cold-curing denture base materials are indicated for: - Manufacture of full and partial dentures 1.
- Repair of full and partial dentures 2.
- ડે. Rebasing of full and partial dentures
-
- Relining of full and partial dentures
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system
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 of Vertex Cold-Curing Denture base material to predicate devices:
- Flexural strength: Vertex Self Curing: 68 MPa; Vertex Castavaria: 79 MPa; Vertex Castapress: 75 MPa
- Flexural modulus: Vertex Self Curing: 2028 MPa; Vertex Castavaria: 2316 MPa; Vertex Castapress: 2293 MPa
- Water absorption: Vertex Self Curing: 20.3 µg/mm³; Vertex Castavaria: 23.2 µg/mm³; Vertex Castapress: 22.1 µg/mm³
- Water solubility: Vertex Self Curing:1.8 µg / mm³; Vertex Castavaria: 1.8 µg / mm³; Vertex Castapress:1.19 ± 0.18 µg / mm³
- Residual monomer: Vertex Self Curing: 3.76 ± 0.15%; Vertex Castavaria: 3.91 ± 0.05%; Vertex Castapress: 3.22 ± 0.06%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Probase Cold (K913655), Major Repair (K082153)
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
K102640v
Submitter: Vertex Dental B.V. Vertex cold-curing denture base material Premarket Notification: Traditional 510(k) MAR 2 5 2011
.
ー
| 510(k) Summary |
|---|
| Submitter Name:
Submitter Address: | Vertex Dental B.V.
Johan van Oldenbarneveltlaan 62,
3705 HJ Zeist
The Netherlands |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number:
Fax Number: | 31 30 69 767 49
31 30 69 551 88 |
| Contact Person:
Contact Address: | William Greenrose
220 River Rd.
Claremont, NH 03743 |
| Phone Number:
Fax Number: | 603-369-3550
603-369-3562 |
| Date Prepared: | August 9, 2010 |
| Device Trade Name: | Vertex Self Curing, Vertex Castavaria, Vertex Castapress |
| Common Name | Denture base material |
| Classification Name,
Number &
Product Code: | resin, denture, relining, repairing, rebasing
872.3760
EBI |
| Predicate Devices: | Probase Cold (K913655), Major Repair (K082153) |
| Device Description
and Statement of
Intended Use | Device Description: Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages |
1
of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system
The Vertex Cold-Curing denture base materials are substantially equivalent to predicate denture base devices presently on the USA market and safety and effectiveness are well documented in dental literature.
Intended Use:
Vertex cold-curing denture base materials are indicated for:
-
- Manufacture of full and partial dentures
-
- Repair of full and partial dentures
- Rebasing of full and partial dentures 3.
- Relining of full and partial dentures ধ :
Summary of Technological Characteristics All of the components found in Vertex™ cold-curing denture base materials have been used in legally marketed devices and were found safe for dental use.
0
2
| Feature | Vertex Cold-Curing Denture
base material | Probase Cold | Major Repair |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | Not yet assigned | K913655 | K082153 |
| Manufacturer | Vertex Dental B.V. | Ivoclar | Major Prodotti Dentari
S.p.a |
| Classification
& Product
Code | 872.3760
EBI | 872.3760
EBI | 872.3760
EBI |
| Indications
for Use | Vertex cold-curing denture
base materials are indicated
for:
- Manufacture of full
and partial dentures - Repair of full and
partial dentures - Rebasing of full and
partial dentures - Relining of full and
partial dentures | The cold-curing ProBase
Cold is suitable for both the
pouring and the packing
technique.
Indication
- Partial dentures
- Combination dentures
- Relining
- Repairs
- Complete dentures | Major.Repair is a cold-
curing polymer for dental
prosthesis. Poly-
methylmethacrylate
based. For reparing and
rebasing dentures.
Powder and liquid.
It is used to: - repair and rebase
prosthesis - temporary prosthesis |
| Physical
Properties | flexural strength:
Vertex Self Curing: 68 MPa
Vertex Castavaria: 79 MPa
Vertex Castapress: 75 MPa | flexural strength: 63.44 ±
4.24 MPa | flexural strength: 66.4
MPa |
| | flexural modulus:
Vertex Self Curing: 2028 MPa
Vertex Castavaria: 2316 MPa
Vertex Castapress: 2293 MPa | flexural modulus: 1832.00
± 88.87 MPa | flexural modulus: 2217
MPa |
| | water absorption:
Vertex Self Curing: 20.3 µg/mm³
Vertex Castavaria: 23.2 µg/mm³
Vertex Castapress: 22.1 µg/mm³ | | water absorption: 21.2
µg/mm³ |
| | Water solubility:
Vertex Self Curing:1.8 µg / mm³
Vertex Castavaria: 1.8 µg / mm³
Vertex Castapress:1.19 ± 0.18
µg / mm³ | | Water solubility: 1.4 µg /
mm³ |
| | Residual monomer:
Vertex Self Curing: 3.76 ± 0.15%
Vertex Castavaria: 3.91 ± 0.05%
Vertex Castapress: 3.22 ± 0.06% | Residual monomer: