NEW STETIC DENTAL AMALGAM ALLOY

• K Number: K140125
• Device Name: NEW STETIC DENTAL AMALGAM ALLOY
• Manufacturer: NEW STETIC
• Date Cleared: 2014-04-29 ( 103 days)
• Product Code: OIV EJJ ELY
• Regulation Number: 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.

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.

Predicate Devices

K940675, K820181, K820967

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a dental amalgam alloy, a material used for fillings, and the description and performance studies focus on its material properties and equivalence to existing amalgam alloys, with no mention of AI or ML.

Therapeutic

Yes
The device is intended as a filling material to restore the morphology and function of teeth that have lost structure due to injuries like cavities or fractures, which is a therapeutic restoration of function.

Diagnostic

No

This device is a dental filling material (dental amalgam alloy) used for restoring tooth morphology and function after injury, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a physical material (dental amalgam alloy) used for filling cavities, not a software program.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to restore the morphology and function of posterior teeth by filling cavities. This is a direct treatment applied to the patient's body.
• Device Description: The device is a dental amalgam alloy used as a filling material. It's a physical material used in a restorative procedure.
• Lack of In Vitro Testing: IVDs are designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for treatment.
• Performance Studies: The performance studies focus on material properties and equivalence to predicate devices, not on diagnostic accuracy or the analysis of biological specimens.

The device is a dental restorative material, which is a medical device, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OIV, EJJ, ELY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

posterior teeth (cavities class I and II in molars and premolars)

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)

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.

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.

K940675, K820181, K820967

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

Regulation Number and Section

§ 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.

Summary

0

K140125

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 USA
John Obrien
Phone: [phone]
Fax: [phone]
Email: [e-mail] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | New Stetic S.A.
Carrera 53 Nº 50-09
Guarne - Antioquia, Colombia
Sandra Maria Montoya
Email: [e-mail]
Phone: [phone]
Fax: [phone] |
| 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.

1

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.

2

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

.

| Product Name
Descriptive

Information	SYBRALOY	CONTOUR	DISPERSALLOY	NU ALLOY DP 40	Differences & Remarks
510(k)	K940675	K820181	K802967
INTENDED USE	Used to provide a
filling material
used in restorative
dentistry when
mixed with
mercury	Intended for use as
a filling material for
oral cavities.	Restorative material
in dental practice.	New Stetic dental
amalgam alloys are
commonly used as a
filling material for
restoring the
morphology and
function of posterior
teeth (cavities class l
and II in molars and
premolars), when
these have lost their
structure due to
injuries such as
cavities or fractures.	None.
All products are intended
to be used as a filling
material in restorative
dentistry.
CHEMICAL COMPOSITION
Silver	39.4 - 43.7%	41%	70%	40%	The content of each
component meets the
requirements of ISO
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 -
51%)	1:0,9
(Mercury: 47%)	1:1
(Mercury: 50%)	(Mercury: 47.5%)
PHYSICAL PROPERTIES
Compressive strength (MPa)
1h:
ISO 24234 Specification: 80
MPa 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 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
Compressive strength (MPa)
24h:
ISO 24234 Specification: 300
MPa 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 of
restoration.
Particle shape	Spherical	Spherical and
Lathe-cut	Spherical and Lathe-
cut	Spherical and Lathe-cut	This parameter is not
specified by a technical
standard. It depends on
the characteristics of
product. This
characteristic does not
affect the performance of
the restoration.
Trituration Time (seconds):
High-speed Amalgamator,
Product form: Capsules	7 - 10 seconds	8 - 10 seconds	10 - 14 seconds	11 seconds	This property depends on
the characteristics of the
product, however, the
variations in the
amalgamator (machine
type, age, line voltage),
even of the same brand,
can modify the speed and
time. It does not affect the
safety and effectiveness of
the product.
Working time (minutes)
Regular Set Capsules	12 min. maximum	12 min. maximum	Not reported	8 min. maximum	This parameter is not
specified by a technical
standard. It depends on the
characteristics of the
product. This difference does
not affect the performance
of the restoration.
	CAS 7440-22-4
	CAS 7440-31-5
	CAS 7440-50-8

K140125 - RTA Response

ക്ഷ

3

| | Descriptive
Information | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP | Differences & Remarks |
|-----------------------------------------------------------------------------------------------------------------|----------------------------|----------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | | | Used to provide a
filling material used
in restorative
dentistry when
mixed with mercury | Intended for use as
a filling material for
oral cavities. | Restorative material
in dental practice. | New Stetic 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. | None.
Both products are intended
to be used as a filling
material in restorative
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
component meets the
requirements of ISO
24234:2004. |
| | | 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)
1h
ISO 24234 Specification: 80
MPa 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 not
exactly the same, the tests
are carried out according to
ISO 24234-2004 and all
products are within
specifications, which ensure
the suitable performance of
restoration. |
| Compressive strength (MPa)
24h
ISO 24234 Specification: 300
MPa 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 and
Lathe-cut | Spherical and Lathe-
cut | Spherical and Lathe-cut | This parameter is not
specified by a technical
standard. It depends on the
characteristics of product.
This characteristic does not
affect the performance of the
restoration. |
| Trituration Time (seconds)
High-speed Amalgamator,
Product form: Capsules | | | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 - 14 seconds | This property depends on
the characteristics of the
product, however, the
variations in the
amalgamator (machine type,
age, line voltage), even of
the same brand, can modify
the speed and time. It does
not affect the safety and
effectiveness of the product. |
| Working time (minutes)
Regular Set Capsules | | | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specified
by a technical standard. It
depends on the characteristics
of the product. This difference
does not affect the
performance of the
restoration. |

4

| | Descriptive
Information | Product Name | SYBRALOY | CONTOUR | DISPERSALLOY | NU ALLOY DP
ACTIVE | Differences & Remarks | |
|-----------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | | | Used to provide a
filling material used
in restorative
dentistry when
mixed with mercury | Intended for use as
a filling material for
oral cavities. | Restorative material
in dental practice. | New Stetic 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. | None.
Both products are intended to
be used as a filling material in
restorative dentistry. | |
| | CHEMICAL COMPOSITION | | | | | | | |
| | | Silver
CAS 7440-22-4 | 39.4 - 43.7% | 41% | 70% | 44.74% | | |
| Alloy | | Tin
CAS 7440-31-5 | 28.8 - 32.5% | 31% | 16% | 31.54% | The content of each | |
| | | Copper
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
(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) 1h
ISO 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) 24h
ISO 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 not
exactly the same, the tests
are carried out according to
ISO 24234-2004 and all
products are within
specifications, which ensure
the suitable performance of
restoration. |
| | | 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 and
Lathe-cut | Spherical and Lathe
cut | Spherical and Lathe cut | This parameter is not
specified by a technical
standard. It depends on the
characteristics of product.
This characteristic does not
affect the performance of the
restoration. | |
| | | Trituration Time (seconds)
High-speed Amalgamator,
Product form: Capsules | 7 - 10 seconds | 8 - 10 seconds | 10 - 14 seconds | 12 seconds | This property depends on the
characteristics of the product,
however, the variations in the
amalgamator (machine type,
age, line voltage), even of the
same brand, can modify the
speed and time. It does not
affect the safety and
effectiveness of the product. | |
| | | Working time (minutes)
Regular Set Capsules | 12 min. maximum | 12 min. maximum | Not reported | 8 min. maximum | This parameter is not specified
by a technical standard. It
depends on the characteristics
of the product. This difference
does not affect the performance
of the restoration. | |
| Product Name
Descriptive
Information | | | SYBRALOY | CONTOUR | DISPERSALLOY | MICRONIC | Differences & Remarks | |
| INTENDED USE | | | Used to provide a
filling material used
in restorative
dentistry when
mixed with mercury | Intended for use as
a filling material for
oral cavities. | Restorative material
in dental practice. | New Stetic 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. | None.
Both products are intended to
be used as a filling material
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
(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) 1h
ISO 24234 Specification: 80
MPa 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)
24h
ISO 24234 Specification: 300
MPa 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 tests
are carried out according to
ISO 24234-2004 and all
products are within
specifications, 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 of
restoration. | |
| 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 and
Lathe-cut | Spherical and Lathe
cut | Lathe-cut | This parameter is not
specified by a technical
standard. It depends on the
characteristics of the product.
This difference does not
affect the performance of the
restoration. | |
| 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 the
characteristics of the product,
however, the variations in the
amalgamator (machine type,
age, line voltage), even of the
same brand, can modify the
speed and time. It does not
affect the safety and
effectiveness of the product. | |
| Working time (minutes)
Regular Set Capsules | | | 12 min. maximum | 12 min. maximum | Not Reported | 7 min. maximum | This parameter is not specified
by a technical standard. It
depends on the characteristics
of the product. This difference
does not affect the
performance of the restoration. | |

5

6

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.

7

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.

8

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 [phone] or [phone] 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 [phone] or [phone] 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

9

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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