ALLOYBOND

K981383 · Southern Dental Industries, Inc. · KLE · Jun 16, 1998 · Dental

Device Facts

• Record ID: K981383
• Device Name: ALLOYBOND
• Applicant: Southern Dental Industries, Inc.
• Product Code: KLE · Dental
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dentin and Enamel adhesive for use with amalgam and resin based restorative materials.

Device Story

Alloybond is a dental adhesive system used by dental professionals to bond restorative materials to tooth structure. It is applied to dentin and enamel surfaces to facilitate the adhesion of amalgam or resin-based restorative materials. The device is used in a clinical dental setting to improve the retention and sealing of dental restorations, potentially reducing microleakage and improving clinical outcomes for patients requiring restorative dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental adhesive system for dentin and enamel bonding. Formulated for compatibility with amalgam and resin-based restorative materials. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a dentin and enamel adhesive in conjunction with amalgam and resin-based restorative materials.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1998

Samantha J. Cheetham Ms. Official Correspondent Southern Dental Industries Incorporated 246 First Street, Suite 204 San Francisco, California 94105

Re : K981383 ALLOYBOND Trade Name: Regulatory Class: II KLE Product Code: March 30, 1998 Dated: Received: April 16, 1998

## Dear Ms. Cheetham:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action, In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Paqe 2 - Ms. Cheetham

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 regulation (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" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A 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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വിക്ഷേത്രം

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## 510(k) Number (if known):

Device Name:

| |

Alloybond

Indications For Use:

Dentin and Enamel adhesive for use with amalgam and resin based restorative materials.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Curres
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1981382

OR

ারী স্বামী বা

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)