(15 days)
Not Found
No
The summary describes a dental amalgam, a traditional filling material, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is a dental amalgam for filling tooth cavities, which is a restorative material used to replace lost tooth structure rather than a therapeutic device that treats disease or provides therapy.
No
The device is described as a dental amalgam used for filling tooth cavities, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "dental amalgam for the filling of tooth cavities," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "dental amalgam for the filling of tooth cavities." This is a material used directly in the body to restore tooth structure.
- Intended Use: The intended use is "for the filling of tooth cavities." This is a restorative procedure performed in vivo (within the body), not a test performed in vitro (outside the body).
The information provided describes a medical device used for direct treatment within the body, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.
Product codes (comma separated list FDA assigned to the subject device)
EJJ
Device Description
Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth cavities
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)
Bestaloy has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US requiations.
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.
LUXALLOY™, DEGUSSA AG K902249
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
§ 872.3070 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.
0
We Dong-Myung Dental Industrial Co. Ltd
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
NOV 1 2 2003
ャンプ
Date: August 28, 2003 ________________________________________________________________________________________________________________________________________________________
- Company and Correspondent making the submission:
| Company | Correspondent | |
|---|---|---|
| Name | We Dong Myung Industrial Co.,Ltd. | Arkin Consulting Group, LLC |
| Address | 156-2, Duk Wu-Ri, Bong Dam-Eup, Hwa | 1733 Canton Lane, |
| Address | Sung-Gun, Kyung Ki-Do, | Marietta, GA, |
| Address | Korea | USA |
| Phone | +82 2 891-2809 | 770-565-6166 |
| Fax | +82 2 891-2846 | 770-565-9762 |
| Contact | Ju Woong Jang | Ronald D. Arkin |
| Internet | orienta@dreamwiz.com | ronarkin@arkinconsulting.com |
2. Device :
Proprietary Name - Bestaloy Common Name – Amalgam Alloy Classification Name -- Dental Materials - Alloys for dental amalgam
3. Predicate Device :
LUXALLOY™, DEGUSSA AG K902249
4. Classifications Names & Citations :
21CFR 872.3050, EJJ, Dental materials - Alloys for dental amalgam. Class2
Guidance document for the preparation of premarket notifications [510(k)'s] for dental amalgams
-
- Description :
Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.
- Description :
156-2, duk Wu-ri, bong-dam-eub, hwa sung, kyung ki, Korea 445
1
-
- Indication for use :
This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II .
- Indication for use :
-
- Contra-indications :
Potential complications associated with the use of Bestaloy may include, but not limited
- Contra-indications :
to:
- Allergies to metals
-
- Review :
Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar.
Bestaloy has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US requiations.
-
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance document for the preparation of premarket notifications [510(k)'s] for dental amalgams" and based on the information provided in this premarket notification We Dong Myung Dental Industrial Co.,Ltd. concludes that Bestaloy is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
We Dong Myung Dental Industrial Co.,Ltd. will update and include in this summary any 10. other information deemed seasonably necessary by the FDA.
-
END
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and head, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
NOV 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
We Dong Myung Dental Industrial Co., Ltd. C/O Mr. Marc M Mouser Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607-8542
Re: K033434
Trade/Device Name: Bestaloy Regulation Number: 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: October 01, 2003 Received: October 28, 2003
Dear Mr. Mouser:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Federal Register.
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.
3
Page 2 - Mr. Mouser
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K (3334) 34
Device Name: Bestaloy
Indication for use: This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21CFR801.109)
Over-The-Counter Use
Susa Penny
(Division Sig. or Agent)
Division Sign-Off) Division of Anesthesion gy, General Hospital Infection Control, D
510(k) Number: K033434