NEW STETIC DENTAL AMALGAM ALLOY
Device Facts
| Record ID | K140125 |
|---|---|
| Device Name | NEW STETIC DENTAL AMALGAM ALLOY |
| Applicant | New Stetic |
| Product Code | OIV · Dental |
| Decision Date | Apr 29, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
Device Story
Dental amalgam alloy consisting of silver, tin, and copper; zinc-free. Supplied as pre-dosed capsules, tablets, or powder. Intended for use by dental professionals as a restorative filling material for posterior teeth (Class I and II cavities). Operates by mixing alloy with elemental mercury to form a restorative material. Applied in dental clinics to restore tooth structure lost to decay or fracture. Benefits include restoration of tooth morphology and function. No software or electronic components involved.
Clinical Evidence
Bench testing only. Performance testing conducted in accordance with ISO 24234:2004 to verify physical properties (compressive strength, creep, dimensional change) and ensure freedom from contamination. Biocompatibility assessment performed via literature review, concluding no new chemical components or additives compared to predicate devices.
Technological Characteristics
Composition: Silver, tin, copper (zinc-free). Form: Pre-dosed capsules, tablets, or powder. Mixing: Manual or mechanical trituration with mercury. Standards: ISO 24234:2004. No software, electronics, or energy source.
Indications for Use
Indicated for patients requiring restoration of posterior teeth (molars and premolars) with Class I or II cavities or fractures to restore morphology and function.
Regulatory Classification
Identification
Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.
Predicate Devices
Submission Summary (Full Text)
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K140125
# APR 2 9 2014
### 510(k) SUMMARY (as required by 807.92)
| Regulatory Correspondent: | AJW Technology Consultants, Inc.<br>445 Apollo Beach Blvd.<br>Apollo Beach, FL 33572 USA<br>John Obrien<br>Phone: 813-645-2855<br>Fax: 813-645-2856<br>Email: jobrien@ajwtech.com |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | New Stetic S.A.<br>Carrera 53 Nº 50-09<br>Guarne - Antioquia, Colombia<br>Sandra Maria Montoya<br>Email: smontoya@newstetic.com<br>Phone: +57 4 550 00 00<br>Fax: +57 4 551 31 34 |
| Date of Summary: | December 17, 2013 |
| Trade/Proprietary Name: | New Stetic Dental Amalgam Alloy |
| Common/Usual Name: | Dental Amalgam, Mercury and Amalgam Alloy |
| Classification Name: | Class II |
| Product Code: | OIV |
| Regulation | 21 CFR 872.3070 |
#### Intended Use:
New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
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#### Device Description:
New Stetic Dental Amalgam Alloys for dental amalgam used as a filling material for oral cavities. They are made of silver, tin and copper and free of zinc. The products are packaged in different forms: pre-dosed capsules, tablets and powder.
Note: Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff was used
| Predicate Device: | K940675 - Sybraloy |
|-------------------|----------------------------------------------|
| | K820181 - Sybron/Kerr Contour |
| | K820967 - Dispersalloy-Dispersed Phase Alloy |
#### Substantial Equivalence:
The New Stetic Dental Amalgam Alloys are substantially equivalent in intended use and technological characteristics to the Sybron Dental Specialties, Inc "Sybraloy" under K940675, the Sybron Corp "Sybron/Kerr Contour under K820181 and the Johnson & Johnson "Dispersalloy-Dispersed Phase Alloy" under K820967. Any difference that exists between the New Stetic Amalgam and the predicate devices has no negative effect on safety or effectiveness.
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## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
.
| Product Name<br>Descriptive<br>Information | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP 40 | Differences & Remarks |
|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K940675 | K820181 | K802967 | | |
| INTENDED USE | Used to provide a<br>filling material<br>used in restorative<br>dentistry when<br>mixed with<br>mercury | Intended for use as<br>a filling material for<br>oral cavities. | Restorative material<br>in dental practice. | New Stetic dental<br>amalgam alloys are<br>commonly used as a<br>filling material for<br>restoring the<br>morphology and<br>function of posterior<br>teeth (cavities class l<br>and II in molars and<br>premolars), when<br>these have lost their<br>structure due to<br>injuries such as<br>cavities or fractures. | None.<br>All products are intended<br>to be used as a filling<br>material in restorative<br>dentistry. |
| CHEMICAL COMPOSITION | | | | | |
| Silver | 39.4 - 43.7% | 41% | 70% | 40% | The content of each<br>component meets the<br>requirements of ISO<br>24234:2004. |
| Tin | 28.8 - 32.5% | 31% | 16% | 31.8% | |
| Copper | 25.8 - 29.8% | 28% | 13% | 28.21% | |
| Zinc | 0% | 0% | 1% | 0% | |
| | 1:0,9 - 1:1,0 | | | 1:0.9 | |
| Alloy-Mercury Ratio | (Mercury: 45 -<br>51%) | 1:0,9<br>(Mercury: 47%) | 1:1<br>(Mercury: 50%) | (Mercury: 47.5%) | |
| PHYSICAL PROPERTIES | | | | | |
| Compressive strength (MPa)<br>1h:<br>ISO 24234 Specification: 80<br>MPa min<br>(Results of Regular Set Tablet) | 185 MPa<br>(26832 PSI) | 124,11 MPa<br>(18000 PSI) | 127,5 MPa<br>(18500 PSI) | 87 MPa<br>(12618 PSI)<br>Result of Lot N°:<br>020713B | Although the results are<br>not exactly the same, our<br>tests are carried out<br>according to ISO 24234-<br>2004 and all products are<br>within specifications,<br>which ensure the suitable |
| Compressive strength (MPa)<br>24h:<br>ISO 24234 Specification: 300<br>MPa min<br>(Results of Regular Set Tablet) | 534 MPa<br>(77450 PSI) | 441,26 MPa<br>(64000 PSI) | 427,5 MPa<br>(62000 PSI) | 364 MPa<br>(52794 PSI)<br>Result of Lot Nº:<br>020713B | |
| Maximum Creep (%):<br>ISO 24234 Specification: 2.0%<br>max<br>(Results of Regular Set Tablet) | 0.08% | 0.10% max | 0.86% | 0.23%<br>Result of Lot Nº:<br>020713B | |
| Dimensional Change (%):<br>ISO 24234 Specification:<br>-0.10 to +0.20 %<br>(Results of Regular Set Tablet) | 0.06% | -0.1% | 0.03% | -0.05% | performance of<br>restoration. |
| Particle shape | Spherical | Spherical and<br>Lathe-cut | Spherical and Lathe-<br>cut | Spherical and Lathe-cut | This parameter is not<br>specified by a technical<br>standard. It depends on<br>the characteristics of<br>product. This<br>characteristic does not<br>affect the performance of<br>the restoration. |
| Trituration Time (seconds):<br>High-speed Amalgamator,<br>Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 11 seconds | This property depends on<br>the characteristics of the<br>product, however, the<br>variations in the<br>amalgamator (machine<br>type, age, line voltage),<br>even of the same brand,<br>can modify the speed and<br>time. It does not affect the<br>safety and effectiveness of<br>the product. |
| Working time (minutes)<br>Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not<br>specified by a technical<br>standard. It depends on the<br>characteristics of the<br>product. This difference does<br>not affect the performance<br>of the restoration. |
| | CAS 7440-22-4 | | | | |
| | CAS 7440-31-5 | | | | |
| | CAS 7440-50-8 | | | | |
K140125 - RTA Response
ക്ഷ
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| | Descriptive<br>Information | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP | Differences & Remarks |
|-----------------------------------------------------------------------------------------------------------------|----------------------------|----------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | | | Used to provide a<br>filling material used<br>in restorative<br>dentistry when<br>mixed with mercury | Intended for use as<br>a filling material for<br>oral cavities. | Restorative material<br>in dental practice. | New Stetic dental<br>amalgam alloys are<br>commonly used as a<br>filling material for<br>restoring the<br>morphology and<br>function of posterior<br>teeth (cavities class I<br>and II in molars and<br>premolars), when<br>these have lost their<br>structure due to<br>injuries such as<br>cavities or fractures. | None.<br>Both products are intended<br>to be used as a filling<br>material in restorative<br>dentistry. |
| Alloy | CHEMICAL COMPOSITION | | | | | | |
| | | Silver CAS 7440-22-4 | 39.4 – 43.7% | 41% | 70% | 44.85% | |
| | | Tin CAS 7440-31-5 | 28.8 – 32.5% | 31% | 16% | 31.95% | |
| | | Copper CAS 7440-50-8 | 25.8 – 29.8% | 28% | 13% | 23.24% | The content of each<br>component meets the<br>requirements of ISO<br>24234:2004. |
| | | Zinc | 0% | 0% | 1% | 0% | |
| | Alloy-Mercury Ratio | | 1:0,9 – 1:1,0<br>(Mercury: 45 –<br>51%) | 1:0,9<br>(Mercury: 47%) | 1:1,0<br>(Mercury: 50%) | 1:0.98<br>(Mercury: 49,6%) | |
| | | PHYSICAL PROPERTIES | | | | | |
| Compressive strength (MPa)<br>1h<br>ISO 24234 Specification: 80<br>MPa min<br>(Results of Regular Set Tablet) | | | 185 MPa<br>(26832 PSI) | 124,1 MPa<br>(18000 PSI) | 127,5 MPa<br>(18500 PSI) | 182 MPa<br>(26397 PSI)<br>Result of Lot N°: 010913 | Although the results are not<br>exactly the same, the tests<br>are carried out according to<br>ISO 24234-2004 and all<br>products are within<br>specifications, which ensure<br>the suitable performance of<br>restoration. |
| Compressive strength (MPa)<br>24h<br>ISO 24234 Specification: 300<br>MPa min<br>(Results of Regular Set Tablet) | | | 534 MPa<br>(77450 PSI) | 441,26 MPa<br>(64000 PSI) | 427,5 MPa<br>(62000 PSI) | 526 MPa<br>(76290 PSI)<br>Result of Lot N°:<br>010913 | |
| Maximum Creep (%):<br>ISO 24234 Specification: 2.0%<br>max<br>(Results of Regular Set Tablet) | | | 0.08% | 0.10% max | 0.86% max | 0.30%<br>Result of Lot N°:<br>010913 | |
| Dimensional Change (%):<br>ISO 24234 Specification:<br>-0.10 to +0.20 %<br>(Results of Regular Set Tablet) | | | 0.06% | -0.1% | 0.03% | -0.05% | |
| Particle shape | | | Spherical | Spherical and<br>Lathe-cut | Spherical and Lathe-<br>cut | Spherical and Lathe-cut | This parameter is not<br>specified by a technical<br>standard. It depends on the<br>characteristics of product.<br>This characteristic does not<br>affect the performance of the<br>restoration. |
| Trituration Time (seconds)<br>High-speed Amalgamator,<br>Product form: Capsules | | | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 - 14 seconds | This property depends on<br>the characteristics of the<br>product, however, the<br>variations in the<br>amalgamator (machine type,<br>age, line voltage), even of<br>the same brand, can modify<br>the speed and time. It does<br>not affect the safety and<br>effectiveness of the product. |
| Working time (minutes)<br>Regular Set Capsules | | | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specified<br>by a technical standard. It<br>depends on the characteristics<br>of the product. This difference<br>does not affect the<br>performance of the<br>restoration. |
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| | Descriptive<br>Information | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP<br>ACTIVE | Differences & Remarks | |
|-----------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | | | Used to provide a<br>filling material used<br>in restorative<br>dentistry when<br>mixed with mercury | Intended for use as<br>a filling material for<br>oral cavities. | Restorative material<br>in dental practice. | New Stetic dental<br>amalgam alloys are<br>commonly used as a<br>filling material for<br>restoring the<br>morphology and<br>function of posterior<br>teeth (cavities class I<br>and II in molars and<br>premolars), when<br>these have lost their<br>structure due to<br>injuries such as<br>cavities or fractures. | None.<br>Both products are intended to<br>be used as a filling material in<br>restorative dentistry. | |
| | CHEMICAL COMPOSITION | | | | | | | |
| | | Silver<br>CAS 7440-22-4 | 39.4 - 43.7% | 41% | 70% | 44.74% | | |
| Alloy | | Tin<br>CAS 7440-31-5 | 28.8 - 32.5% | 31% | 16% | 31.54% | The content of each | |
| | | Copper<br>CAS 7440-50-8 | 25.8 - 29.8% | 28% | 13% | 23.96% | component meets the | |
| | | Zinc | 0% | 0% | 1% | 0% | requirements of ISO | |
| | Alloy-Mercury Ratio | | 1:0,9 - 1:1,0<br>(Mercury: 45 - 51%) | 1:0.9<br>(Mercury: 47%) | 1:1,0<br>(Mercury: 50%) | 1:0.98<br>(Mercury: 49.6%) | 24234:2004. | |
| | | PHYSICAL PROPERTIES | | | | | | |
| | | Compressive strength (MPa) 1h<br>ISO 24234 Specification: 80 MPa min<br>(Results of Regular Set Tablet) | | 185 MPa<br>(26832 PSI) | 124,11 MPa<br>(18000 PSI) | 127,5 MPa<br>(18500 PSI) | 159 MPa<br>(23061 PSI)<br>Result of Lot Nº: 010713 | |
| | | Compressive strength (MPa) 24h<br>ISO 24234 Specification: 300 MPa min<br>(Results of Regular Set Tablet) | | 534 MPa<br>(77450 PSI) | 441,26 MPa<br>(64000 PSI) | 427,5 MPa<br>(62000 PSI) | 500 MPa<br>(72519 PSI)<br>Result of Lot Nº:<br>010713 | Although the results are not<br>exactly the same, the tests<br>are carried out according to<br>ISO 24234-2004 and all<br>products are within<br>specifications, which ensure<br>the suitable performance of<br>restoration. |
| | | Maximum Creep (%):<br>ISO 24234 Specification: 2.0% max<br>(Results of Regular Set Tablet) | | 0.08% | 0.10% max | 0.86% max | 0.18%<br>Result of Lot Nº:<br>010713 | |
| | | Dimensional Change (%):<br>ISO 24234 Specification:<br>-0.10 to +0.20 %<br>(Results of Regular Set Tablet) | | 0.06% | -0.1% | 0.03% | -0.06% | |
| | | Particle shape | Spherical | Spherical and<br>Lathe-cut | Spherical and Lathe<br>cut | Spherical and Lathe cut | This parameter is not<br>specified by a technical<br>standard. It depends on the<br>characteristics of product.<br>This characteristic does not<br>affect the performance of the<br>restoration. | |
| | | Trituration Time (seconds)<br>High-speed Amalgamator,<br>Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 seconds | This property depends on the<br>characteristics of the product,<br>however, the variations in the<br>amalgamator (machine type,<br>age, line voltage), even of the<br>same brand, can modify the<br>speed and time. It does not<br>affect the safety and<br>effectiveness of the product. | |
| | | Working time (minutes)<br>Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specified<br>by a technical standard. It<br>depends on the characteristics<br>of the product. This difference<br>does not affect the performance<br>of the restoration. | |
| Product Name<br>Descriptive<br>Information | | | SYBRALOY | CONTOUR | DISPERSALLOY | MICRONIC | Differences & Remarks | |
| INTENDED USE | | | Used to provide a<br>filling material used<br>in restorative<br>dentistry when<br>mixed with mercury | Intended for use as<br>a filling material for<br>oral cavities. | Restorative material<br>in dental practice. | New Stetic dental<br>amalgam alloys are<br>commonly used as a<br>filling material for<br>restoring the<br>morphology and<br>function of posterior<br>teeth (cavities class I<br>and II in molars and<br>premolars), when these<br>have lost their structure<br>due to injuries such as<br>cavities or fractures. | None.<br>Both products are intended to<br>be used as a filling material<br>in restorative dentistry. | |
| | | CHEMICAL COMPOSITION | | | | | | |
| | Silver | CAS 7440-22-4 | 39.4 - 43.7% | 41% | 70% | 70.14% | | |
| Alloy | Tin | CAS 7440-31-5 | 28.8 - 32.5% | 31% | 16% | 26.89% | The content of each | |
| | Copper | CAS 7440-50-8 | 25.8 - 29.8% | 28% | 13% | 3.86% | component meets the | |
| | Zinc | | 0% | 0% | 1% | 0% | requirements of ISO | |
| | Alloy-Mercury Ratio | | 1:0,9 - 1:1,0<br>(Mercury: 45 -<br>51%) | 1:0,9<br>(Mercury: 47%) | 1:1<br>(Mercury: 50%) | 1:1.1 - 1:1.2<br>(Mercury: 52.4% -<br>54.5%) | 24234:2004. | |
| | | PHYSICAL PROPERTIES | | | | | | |
| Compressive strength (MPa) 1h<br>ISO 24234 Specification: 80<br>MPa min<br>(Results of Regular Set Tablet) | | | 185 MPa<br>(26832 PSI) | 124,11 MPa<br>(18000 PSI) | 127,5 MPa<br>(18500 PSI) | 183 MPa<br>(26542 PSI)<br>Result of Lot Nº: 010913M | Although the results are not | |
| Compressive strength (MPa)<br>24h<br>ISO 24234 Specification: 300<br>MPa min<br>(Results of Regular Set Tablet) | | | 534 MPa<br>(77450 PSI) | 441,26 MPa<br>(64000 PSI) | 427,5 MPa<br>(62000 PSI) | 398 MPa<br>(57725 PSI)<br>Result of Lot Nº:<br>010913M | exactly the same, the tests<br>are carried out according to<br>ISO 24234-2004 and all<br>products are within<br>specifications, which ensure | |
| Maximum Creep (%):<br>ISO 24234 Specification: 2.0%<br>max<br>(Results of Regular Set Tablet) | | | 0.08% | 0.10% max | 0.86% max | 0.20%<br>Result of Lot Nº:<br>010913M | the suitable performance of<br>restoration. | |
| Dimensional Change (%):<br>ISO 24234 Specification:<br>-0.10 to +0.20 %<br>(Results of Regular Set Tablet) | | | 0.06% | -0.1% | 0.03% | -0.03% | | |
| Particle shape | | | Spherical | Spherical and<br>Lathe-cut…
