(103 days)
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.
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.
The provided 510(k) summary for K140125 describes the New Stetic Dental Amalgam Alloys and compares them to predicate devices to establish substantial equivalence. The "study" here refers to the performance testing conducted to meet regulatory standards and demonstrate equivalence rather than a clinical trial on human subjects improved with the AI.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Details for K140125: New Stetic Dental Amalgam Alloys
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is assessed against the specifications outlined in ISO 24234:2004 for dental amalgam. The tables below compile the acceptance criteria from this ISO standard and the reported performance of the New Stetic Dental Amalgam Alloys (NU ALLOY DP 40, NU ALLOY DP, NU ALLOY DP ACTIVE, and MICRONIC).
Acceptance Criteria and Device Performance (NU ALLOY DP 40)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP 40, Lot N°: 020713B) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 87 MPa (12618 PSI) |
| Compressive strength (24h) | 300 MPa min | 364 MPa (52794 PSI) |
| Maximum Creep (%) | 2.0% max | 0.23% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.05% |
Acceptance Criteria and Device Performance (NU ALLOY DP)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP, Lot N°: 010913) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 182 MPa (26397 PSI) |
| Compressive strength (24h) | 300 MPa min | 526 MPa (76290 PSI) |
| Maximum Creep (%) | 2.0% max | 0.30% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.05% |
Acceptance Criteria and Device Performance (NU ALLOY DP ACTIVE)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (NU ALLOY DP ACTIVE, Lot N°: 010713) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 159 MPa (23061 PSI) |
| Compressive strength (24h) | 300 MPa min | 500 MPa (72519 PSI) |
| Maximum Creep (%) | 2.0% max | 0.18% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.06% |
Acceptance Criteria and Device Performance (MICRONIC)
| Property | Acceptance Criteria (ISO 24234:2004) | Reported Device Performance (MICRONIC, Lot N°: 010913M) |
|---|---|---|
| Compressive strength (1h) | 80 MPa min | 183 MPa (26542 PSI) |
| Compressive strength (24h) | 300 MPa min | 398 MPa (57725 PSI) |
| Maximum Creep (%) | 2.0% max | 0.20% |
| Dimensional Change (%) | -0.10 to +0.20 % | -0.03% |
For all products, the report states: "Although the results are not exactly the same, our tests are carried out according to ISO 24234-2004 and all products are within specifications, which ensure the suitable performance of restoration."
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "Performance /Non-Clinical Testing" which was "completed in accordance to ISO 24234:2004". The results for each alloy type are provided with "Lot N°", indicating that samples from specific production lots were tested. However, the exact sample size (number of specimens per test) used for each physical property measurement is not explicitly stated in this document. The provenance of the data is from New Stetic S.A., located in Guarne - Antioquia, Colombia, who are the submitters of the 510(k). The testing is retrospective, as it was performed on finished product lots.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This document does not describe the establishment of a "ground truth" by experts in the context of diagnostic interpretation. Instead, the "ground truth" refers to objective physical and chemical properties measured against an international standard (ISO 24234:2004). There is no mention of human experts being involved in establishing the ground truth for these physical and chemical performance tests.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The performance is based on objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a submission for a dental material (amalgam alloy), not an AI-assisted diagnostic device. Therefore, a study comparing human reader performance with and without AI assistance is not relevant and was not conducted.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical material, not an algorithm or software. Its performance is evaluated through material science testing.
7. Type of Ground Truth Used:
The ground truth used is the objective physical and chemical specifications defined by the international standard ISO 24234:2004. This standard sets the minimum or maximum acceptable values for properties like compressive strength, creep, and dimensional change.
8. Sample Size for the Training Set:
Not applicable. This is a physical dental material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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APR 2 9 2014
510(k) SUMMARY (as required by 807.92)
| Regulatory Correspondent: | AJW Technology Consultants, Inc.445 Apollo Beach Blvd.Apollo Beach, FL 33572 USAJohn ObrienPhone: 813-645-2855Fax: 813-645-2856Email: jobrien@ajwtech.com |
|---|---|
| Submitter of 510(k): | New Stetic S.A.Carrera 53 Nº 50-09Guarne - Antioquia, ColombiaSandra Maria MontoyaEmail: smontoya@newstetic.comPhone: +57 4 550 00 00Fax: +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 NameDescriptiveInformation | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP 40 | Differences & Remarks |
|---|---|---|---|---|---|
| 510(k) | K940675 | K820181 | K802967 | ||
| INTENDED USE | Used to provide afilling materialused in restorativedentistry whenmixed withmercury | Intended for use asa filling material fororal cavities. | Restorative materialin dental practice. | New Stetic dentalamalgam alloys arecommonly used as afilling material forrestoring themorphology andfunction of posteriorteeth (cavities class land II in molars andpremolars), whenthese have lost theirstructure due toinjuries such ascavities or fractures. | None.All products are intendedto be used as a fillingmaterial in restorativedentistry. |
| CHEMICAL COMPOSITION | |||||
| Silver | 39.4 - 43.7% | 41% | 70% | 40% | The content of eachcomponent meets therequirements of ISO24234:2004. |
| 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 -51%) | 1:0,9(Mercury: 47%) | 1:1(Mercury: 50%) | (Mercury: 47.5%) | |
| PHYSICAL PROPERTIES | |||||
| Compressive strength (MPa)1h:ISO 24234 Specification: 80MPa min(Results of Regular Set Tablet) | 185 MPa(26832 PSI) | 124,11 MPa(18000 PSI) | 127,5 MPa(18500 PSI) | 87 MPa(12618 PSI)Result of Lot N°:020713B | Although the results arenot exactly the same, ourtests are carried outaccording to ISO 24234-2004 and all products arewithin specifications,which ensure the suitable |
| Compressive strength (MPa)24h:ISO 24234 Specification: 300MPa min(Results of Regular Set Tablet) | 534 MPa(77450 PSI) | 441,26 MPa(64000 PSI) | 427,5 MPa(62000 PSI) | 364 MPa(52794 PSI)Result of Lot Nº:020713B | |
| Maximum Creep (%):ISO 24234 Specification: 2.0%max(Results of Regular Set Tablet) | 0.08% | 0.10% max | 0.86% | 0.23%Result of Lot Nº:020713B | |
| Dimensional Change (%):ISO 24234 Specification:-0.10 to +0.20 %(Results of Regular Set Tablet) | 0.06% | -0.1% | 0.03% | -0.05% | performance ofrestoration. |
| Particle shape | Spherical | Spherical andLathe-cut | Spherical and Lathe-cut | Spherical and Lathe-cut | This parameter is notspecified by a technicalstandard. It depends onthe characteristics ofproduct. Thischaracteristic does notaffect the performance ofthe restoration. |
| Trituration Time (seconds):High-speed Amalgamator,Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 11 seconds | This property depends onthe characteristics of theproduct, however, thevariations in theamalgamator (machinetype, age, line voltage),even of the same brand,can modify the speed andtime. It does not affect thesafety and effectiveness ofthe product. |
| Working time (minutes)Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is notspecified by a technicalstandard. It depends on thecharacteristics of theproduct. This difference doesnot affect the performanceof the restoration. |
| CAS 7440-22-4 | |||||
| CAS 7440-31-5 | |||||
| CAS 7440-50-8 |
K140125 - RTA Response
ക്ഷ
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| DescriptiveInformation | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP | Differences & Remarks | |
|---|---|---|---|---|---|---|---|
| INTENDED USE | Used to provide afilling material usedin restorativedentistry whenmixed with mercury | Intended for use asa filling material fororal cavities. | Restorative materialin dental practice. | New Stetic dentalamalgam alloys arecommonly used as afilling material forrestoring themorphology andfunction of posteriorteeth (cavities class Iand II in molars andpremolars), whenthese have lost theirstructure due toinjuries such ascavities or fractures. | None.Both products are intendedto be used as a fillingmaterial in restorativedentistry. | ||
| 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 eachcomponent meets therequirements of ISO24234:2004. | ||
| Zinc | 0% | 0% | 1% | 0% | |||
| Alloy-Mercury Ratio | 1:0,9 – 1:1,0(Mercury: 45 –51%) | 1:0,9(Mercury: 47%) | 1:1,0(Mercury: 50%) | 1:0.98(Mercury: 49,6%) | |||
| PHYSICAL PROPERTIES | |||||||
| Compressive strength (MPa)1hISO 24234 Specification: 80MPa min(Results of Regular Set Tablet) | 185 MPa(26832 PSI) | 124,1 MPa(18000 PSI) | 127,5 MPa(18500 PSI) | 182 MPa(26397 PSI)Result of Lot N°: 010913 | Although the results are notexactly the same, the testsare carried out according toISO 24234-2004 and allproducts are withinspecifications, which ensurethe suitable performance ofrestoration. | ||
| Compressive strength (MPa)24hISO 24234 Specification: 300MPa min(Results of Regular Set Tablet) | 534 MPa(77450 PSI) | 441,26 MPa(64000 PSI) | 427,5 MPa(62000 PSI) | 526 MPa(76290 PSI)Result of Lot N°:010913 | |||
| Maximum Creep (%):ISO 24234 Specification: 2.0%max(Results of Regular Set Tablet) | 0.08% | 0.10% max | 0.86% max | 0.30%Result of Lot N°:010913 | |||
| Dimensional Change (%):ISO 24234 Specification:-0.10 to +0.20 %(Results of Regular Set Tablet) | 0.06% | -0.1% | 0.03% | -0.05% | |||
| Particle shape | Spherical | Spherical andLathe-cut | Spherical and Lathe-cut | Spherical and Lathe-cut | This parameter is notspecified by a technicalstandard. It depends on thecharacteristics of product.This characteristic does notaffect the performance of therestoration. | ||
| Trituration Time (seconds)High-speed Amalgamator,Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 - 14 seconds | This property depends onthe characteristics of theproduct, however, thevariations in theamalgamator (machine type,age, line voltage), even ofthe same brand, can modifythe speed and time. It doesnot affect the safety andeffectiveness of the product. | ||
| Working time (minutes)Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specifiedby a technical standard. Itdepends on the characteristicsof the product. This differencedoes not affect theperformance of therestoration. |
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| DescriptiveInformation | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DPACTIVE | Differences & Remarks | ||
|---|---|---|---|---|---|---|---|---|
| INTENDED USE | Used to provide afilling material usedin restorativedentistry whenmixed with mercury | Intended for use asa filling material fororal cavities. | Restorative materialin dental practice. | New Stetic dentalamalgam alloys arecommonly used as afilling material forrestoring themorphology andfunction of posteriorteeth (cavities class Iand II in molars andpremolars), whenthese have lost theirstructure due toinjuries such ascavities or fractures. | None.Both products are intended tobe used as a filling material inrestorative dentistry. | |||
| CHEMICAL COMPOSITION | ||||||||
| SilverCAS 7440-22-4 | 39.4 - 43.7% | 41% | 70% | 44.74% | ||||
| Alloy | TinCAS 7440-31-5 | 28.8 - 32.5% | 31% | 16% | 31.54% | The content of each | ||
| CopperCAS 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(Mercury: 45 - 51%) | 1:0.9(Mercury: 47%) | 1:1,0(Mercury: 50%) | 1:0.98(Mercury: 49.6%) | 24234:2004. | |||
| PHYSICAL PROPERTIES | ||||||||
| Compressive strength (MPa) 1hISO 24234 Specification: 80 MPa min(Results of Regular Set Tablet) | 185 MPa(26832 PSI) | 124,11 MPa(18000 PSI) | 127,5 MPa(18500 PSI) | 159 MPa(23061 PSI)Result of Lot Nº: 010713 | ||||
| Compressive strength (MPa) 24hISO 24234 Specification: 300 MPa min(Results of Regular Set Tablet) | 534 MPa(77450 PSI) | 441,26 MPa(64000 PSI) | 427,5 MPa(62000 PSI) | 500 MPa(72519 PSI)Result of Lot Nº:010713 | Although the results are notexactly the same, the testsare carried out according toISO 24234-2004 and allproducts are withinspecifications, which ensurethe suitable performance ofrestoration. | |||
| Maximum Creep (%):ISO 24234 Specification: 2.0% max(Results of Regular Set Tablet) | 0.08% | 0.10% max | 0.86% max | 0.18%Result of Lot Nº:010713 | ||||
| Dimensional Change (%):ISO 24234 Specification:-0.10 to +0.20 %(Results of Regular Set Tablet) | 0.06% | -0.1% | 0.03% | -0.06% | ||||
| Particle shape | Spherical | Spherical andLathe-cut | Spherical and Lathecut | Spherical and Lathe cut | This parameter is notspecified by a technicalstandard. It depends on thecharacteristics of product.This characteristic does notaffect the performance of therestoration. | |||
| Trituration Time (seconds)High-speed Amalgamator,Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 seconds | This property depends on thecharacteristics of the product,however, the variations in theamalgamator (machine type,age, line voltage), even of thesame brand, can modify thespeed and time. It does notaffect the safety andeffectiveness of the product. | |||
| Working time (minutes)Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specifiedby a technical standard. Itdepends on the characteristicsof the product. This differencedoes not affect the performanceof the restoration. | |||
| Product NameDescriptiveInformation | SYBRALOY | CONTOUR | DISPERSALLOY | MICRONIC | Differences & Remarks | |||
| INTENDED USE | Used to provide afilling material usedin restorativedentistry whenmixed with mercury | Intended for use asa filling material fororal cavities. | Restorative materialin dental practice. | New Stetic dentalamalgam alloys arecommonly used as afilling material forrestoring themorphology andfunction of posteriorteeth (cavities class Iand II in molars andpremolars), when thesehave lost their structuredue to injuries such ascavities or fractures. | None.Both products are intended tobe used as a filling materialin 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(Mercury: 45 -51%) | 1:0,9(Mercury: 47%) | 1:1(Mercury: 50%) | 1:1.1 - 1:1.2(Mercury: 52.4% -54.5%) | 24234:2004. | |||
| PHYSICAL PROPERTIES | ||||||||
| Compressive strength (MPa) 1hISO 24234 Specification: 80MPa min(Results of Regular Set Tablet) | 185 MPa(26832 PSI) | 124,11 MPa(18000 PSI) | 127,5 MPa(18500 PSI) | 183 MPa(26542 PSI)Result of Lot Nº: 010913M | Although the results are not | |||
| Compressive strength (MPa)24hISO 24234 Specification: 300MPa min(Results of Regular Set Tablet) | 534 MPa(77450 PSI) | 441,26 MPa(64000 PSI) | 427,5 MPa(62000 PSI) | 398 MPa(57725 PSI)Result of Lot Nº:010913M | exactly the same, the testsare carried out according toISO 24234-2004 and allproducts are withinspecifications, which ensure | |||
| Maximum Creep (%):ISO 24234 Specification: 2.0%max(Results of Regular Set Tablet) | 0.08% | 0.10% max | 0.86% max | 0.20%Result of Lot Nº:010913M | the suitable performance ofrestoration. | |||
| Dimensional Change (%):ISO 24234 Specification:-0.10 to +0.20 %(Results of Regular Set Tablet) | 0.06% | -0.1% | 0.03% | -0.03% | ||||
| Particle shape | Spherical | Spherical andLathe-cut | Spherical and Lathecut | Lathe-cut | This parameter is notspecified by a technicalstandard. It depends on thecharacteristics of the product.This difference does notaffect the performance of therestoration. | |||
| Trituration Time (seconds)High-speed Amalgamator,Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 7 - 14 seconds | This property depends on thecharacteristics of the product,however, the variations in theamalgamator (machine type,age, line voltage), even of thesame brand, can modify thespeed and time. It does notaffect the safety andeffectiveness of the product. | |||
| Working time (minutes)Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not Reported | 7 min. maximum | This parameter is not specifiedby a technical standard. Itdepends on the characteristicsof the product. This differencedoes not affect theperformance of the restoration. |
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Sterilization and Shelf Life:
New Stetic has been producing alloys for dental amalgam since the late 80's, since that time the product has shown its clinical effectiveness and safety, as well as its stability at storage conditions. The product is produced as a combination of elemental mercury and amalgam alloy composed of silver, tin and copper, but the product is supplied separately: alloy as powder or tablet and mercury in a sachet. These components have been used by many companies around the world and for many years, and they have always shown an excellent stability during the storage time. For that reason an expiration date has not been considered necessary in order to guarantee its functionality.
Performance /Non-Clinical Testing:
Performance testing was completed in accordance to ISO 24234:2004 as recommended in the FDA Guidance Document "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff. The testing was performed to show that the product is free from contamination.
Based on the data generated from the testing on it can be concluded that the New Stetic Dental Amalgam Alloys are substantially equivalent to the Sybron Dental Specialties, Inc Sybraloy, the Sybron Corp Contour and Johnson & Johnson Professionals, Inc Dispersalloy.
Biocompatibility
A biocompatibility summary was completed to demonstrate that the New Stetic Dental Amalgam Alloys are equivalent to the predicates. This includes supporting literature in lieu of performing biocompatibility testing. The New Stetic Dental Amalgam Alloys do not contain any new chemical components or additives nor do they use any new technology.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WC 166-G61 Silver Spring, MI) 20993-0002
April 29, 2014
New Stetic, S.A. C/O John O`Brien Consultant AJW Technology Consultants, Incorporated 445 Apollo Beach Blvd.. Apollo Beach, FL 33572
Re: K140125
Trade/Device Name: New Stetic Dental Amalgam Alloy (NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic) Regulation Number: 21 CFR 872.3070 Regulation Name: Dental Amalgam, Mercury, and Amalgam Alloy Regulatory Class: II Product Codes: OIV. EJJ. EJJ. ELY Dated: January 28. 2014 Received: January 31, 2014
Dear Mr. O Brien:
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 I ou may, diere.orer inans 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 warrantics. We remind you, however, that device labeling must be truthful and not misleading.
11 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 Eederal Register.
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Page 2 - Mr. O'Brien
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 device-related 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/ResourcesforYou/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/ReportaProblem/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 vours.
Susan Ruma, DDS, MA
Erin I. Keith, 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
510(k) Number (if known): K140125
Device Name: New Stetic Dental Amalgam Alloy
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.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A Green S
2014.04.28 08:02:02 -04'00'
K140125 - RTA Response
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§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
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.(b)
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.