K040547 · Harry J. Bosworth Co. · DYH · Mar 19, 2004 · Dental
Device Facts
Record ID
K040547
Device Name
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
Applicant
Harry J. Bosworth Co.
Product Code
DYH · Dental
Decision Date
Mar 19, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3750
Device Class
Class 2
Indications for Use
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket. The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands. The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.
Device Story
Aegis® ORTHO is a filled, two-component, dual-cure resin adhesive; used by dental professionals for bonding orthodontic brackets/bands and cementing dental restorations. Operates via light-activation or chemical-cure; chemical-cure mode utilized when bracket opacity prevents sufficient light exposure. Applied in clinical dental settings to facilitate secure attachment of orthodontic hardware or restorative dental work. Benefits patient by providing versatile curing options to ensure reliable bonding in various clinical scenarios.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Filled, two-component, dual-cure (light-activated and chemical-cure) resin-based adhesive. Designed for dental bonding and cementation applications.
Indications for Use
Indicated for bonding orthodontic brackets and bands to teeth, and for cementing dental restorations (crowns, bridges, veneers, inlays, onlays) in patients requiring a filled, two-component, dual-cure (light-activated/chemical-cure) or self-cure resin adhesive.
Regulatory Classification
Identification
A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.
Submission Summary (Full Text)
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
## Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Rc: K040547
Trade/Device Name: Aegis® ORTHO Dual-Cured Orthodontic Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH and EMA Dated: February 27, 2004 Received: March 09, 2004
Dear Ms. Goldstein:
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 approvisions 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.
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## Page 2 -- Ms. Mildred M. Goldstein
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a sassamming with other requirements mean that ITDA has made a decemmand regulations administered by other Federal agencies. of the Act of ally rederal statutes and registeredts, including, but not limited to: registration You must contint an the Her Her Prece Proq.21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirents as set form in the quality by sections (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) This letter will anow you to begin mained of substantial equivalence of your device to a premarket nothleation. THC FDA mainly or salessification 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), If you desire specific advice for your as at (301) 594-4613. Additionally, for questions on please contact the Office of Compliance at ( s o) , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , the promotion and the regulation entitled, "Misbranding by reference to (201) 594-4059. Also, please note are are not obtain. Other general information on premarket notification (21 Cr Act may be obtained from the Division of Small your responsibilities ander the 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
Sincercly yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
K040547
510(K) Number:
Device Name: Aegis-ORTHO Dual-Cured Orthodontic Adhesive
## INDICATIONS FOR USE:
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.
The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.
(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)
Susa Russo
ction Control Dental
510(k) Number:
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