D-SIGN III (R&D PROJECT DW264#7)

K990077 · Ivoclar North America, Inc. · EJS · Feb 12, 1999 · Dental

Device Facts

• Record ID: K990077
• Device Name: D-SIGN III (R&D PROJECT DW264#7)
• Applicant: Ivoclar North America, Inc.
• Product Code: EJS · Dental
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.

Device Story

D-Sign III is a dental restorative material used by dental professionals for fabrication of crowns and bridges. It serves as a substrate or framework component compatible with conventional feldspathic porcelains. The device is indicated for various prosthetic applications including 3/4 crowns, telescopic crowns, conus crowns, posts, attachments, and both short and long span bridges. It is intended for prescription use in a clinical or laboratory setting to restore dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental restorative material designed for use with conventional feldspathic porcelains. Formulated for use in fixed prosthodontics including crowns and bridges. No specific material composition, energy source, or software components described.

Indications for Use

Indicated for use in dental restorations including 3/4 crowns, telescopic crowns, conus crowns, posts, attachments, short and long span bridges, and porcelain-fused-to-metal (PFM) crowns, utilizing conventional feldspathic porcelains.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K990077 D-Sign III (R&D Project DW264 #7) Trade Name: Requlatory Class: II Product Code: EJS Dated: January 6, 1999 Received: January 11, 1999

Dear Mr. Mancuso:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS), for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Mancuso

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990077
Page 1 of 1

510(k) Number (if known): K99007-

Sign 11 Device Name: 0

Indications For Use:

Indications for Use: D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.

(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 Runn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number