GOLD DENTAL CASTING ALLOYS

K033279 · Bego U.S.A. · EJT · Jan 15, 2004 · Dental

Device Facts

• Record ID: K033279
• Device Name: GOLD DENTAL CASTING ALLOYS
• Applicant: Bego U.S.A.
• Product Code: EJT · Dental
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations. Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations. Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations. Bio Platinlloyd is a precious dental casting alloy to make metal fused to ceramic dental restorations. Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations. Begorex 45 is a precious dental casting alloy to make metal fused to ceramic dental restorations. PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations. Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations. Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations. Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations. Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations. PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations. Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations. Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations. Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations. Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations.

Device Story

Precious dental casting alloys used by dental technicians in laboratory settings to fabricate dental restorations (crowns, bridges, metal-fused-to-ceramic). Alloys are cast into specific shapes to restore tooth structure. Final restorations are placed by dentists. Benefits include biocompatibility and structural integrity for dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Precious metal-based dental casting alloys. Formulated for casting crown, bridge, and metal-fused-to-ceramic restorations. Class II medical devices.

Indications for Use

Indicated for dental patients requiring crown, bridge, or metal-fused-to-ceramic dental restorations. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{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 [phone]. 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 [phone] or [phone] 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