(97 days)
Not Found
Not Found
No
The device is described as a precious dental casting alloy, which is a material, not a software or system that would typically incorporate AI/ML. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a precious dental casting alloy used to make dental restorations like crowns, bridges, and metal-fused ceramic restorations, which are used to replace or restore teeth. They are not therapeutic in nature as they do not treat or cure any disease.
No
The input describes dental casting alloys used to make dental restorations, which are materials for making devices, not diagnostic tools.
No
The device description clearly states "Gold Dental Casting Alloys," which are physical materials, not software. The intended use also describes the use of these alloys in creating dental restorations, further indicating a physical product.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use for all listed devices is to make dental restorations (crowns, bridges, metal fused to ceramic). This is a manufacturing process for a medical device (dental prosthesis), not a diagnostic test performed on a biological sample.
- Device Description: The description "Gold Dental Casting Alloys" further reinforces that these are materials used in the creation of dental devices.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, these devices are materials used in the fabrication of dental prostheses, which are medical devices, but they are not IVDs themselves.
N/A
Intended Use / Indications for Use
BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Not Found
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)
Not Found
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.
Not Found
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
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. Williams Oremus General Manager Bego, USA 24 Albion Road, Suite 103 Lincoln, Rhode Island 02865
Re: K033279/S1
Trade/Device Name: Gold Dental Casting Alloys Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: January 7, 2004 Received: January 12, 2004
Dear Mr. Oremus:
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 cither 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.
1
Page 2 - Mr. Oremus
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); 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.
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
2
Page of
510(k) Number (if known):
Device Name: BegoStar Precious Dental Alloy
Indications For Use: BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ! (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
I av
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Control Dental Devices Division of Anesthestology
Infection Control, Dental Devices
510(k) Number:
3
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:_Pontorex G Precious Dental Alloy
Indications For Use: Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usel (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Orantal Dantal Davices intection Control, Dental S
510(k) Number ..
4
Page__________________________________________________________________________________________________________________________________________________________________________ _of 510(k) Number (if known):
Device Name: Platinlloyd KF Precious Dental Alloy
Indications For Use: Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
r breision Sign-Off) വംlalon of Anesthesiology, General Hospital to'ection Control. Dental Devices
CTO(k) Number __
5
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Bio Platinllovd Precious Dental Alloy
Indications For Use: Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
W Jer
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number .
6
of Page -
510(k) Number (if known):
Device Name: Begopal S Precious Dental Alloy
Indications For Use: Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Waar
(Division Sign-Off) Division of Anesthesiology, General Hospital, infection Control, Dental Devices
510(k) Number:_
7
Page __ _of
510(k) Number (if known):
Device Name: Begorex 45 Precious Dental Alloy
Indications For Use: Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
NOW
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Olvision Control, Dental Devices
510(k) Number _
8
Page_____of
.
دمت دخت دختند
510(k) Number (if known):
Device Name: PontoStar Ti Precious Dental Alloy
Indications For Use: PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Wag while
(Division Sign-Off) Division of Anesthesiology, General Hospital, intection Control, Dental Devices
510(k) Number: RC033279
9
Page____of
510(k) Number (if known):
Device Name: Pontolloyd G Precious Dental Alloy
Indications For Use: Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Rumps
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033279
10
Page_______of
510(k) Number (if known):
Device Name: Bio Pontostar XL Precious Dental Alloy
Indications For Use: Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number KC233279
11
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Begollovd 60 Precious Dental Alloy
Indications For Use: Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Usc
(Optional Format 1-2-96)
Week
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Coutral, Dental Devices Division Control, Denta
510(k) Number: K033279
12
of Page_
510(k) Number (if known):
Device Name: Begolloyd PF Precious Dental Alloy
Indications For Use: Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
Suresh Kumar
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, General Devices Division of Anesthesionesial Devices
510(k) Number: K033279
13
of Page
510(k) Number (if known):
Device Name: PontoStar G Precious Dental Alloy
Indications For Use: PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﻤﺎ Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Suser Runa
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Antol, Dental Devices
510(k) Number. KC230274
14
Page of
510(k) Number (if known):
Device Name: Gold EWL H Precious Dental Alloy
Indications For Use: Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Pumpr
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KC033275
15
Page_of
510(k) Number (if known):
Device Name: PlatinIloyd M Precious Dental Alloy
Indications For Use: Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Super Runper
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Ocentral, Devices Division of Anesthosions of Anestion Control. Dental Devices
510(k) Number. 10033274
16
Page__________________________________________________________________________________________________________________________________________________________________________
:
510(k) Number (if known):
Device Name: Begopal 300 Precious Dental Alloy
Indications For Use: Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Rosser
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Ancolnoolshoolsholly
Infection Control, Dental Devices
510(k) Number: K033277
17
Page of
510(k) Number (if known):
Device Name: Begostar LFC Precious Dental Alloy
Indications For Use: Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
OR
(Optional Format 1-2-96)
Susan Romer
(Division Sign-Off) Division of Anasthesiology, General Hospital, Intection Control, Dental Devices
510(k) Numbe