IBOND GLUMA INSIDE

K022612 · Heraeus Kulzer, Inc. · KLE · Oct 28, 2002 · Dental

Device Facts

• Record ID: K022612
• Device Name: IBOND GLUMA INSIDE
• Applicant: Heraeus Kulzer, Inc.
• Product Code: KLE · Dental
• Decision Date: Oct 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bonding composite, comporner and Polyglas® resins to the tooth structure as well for indirect restorations (e.g. Anglass®, procelain) and sealing of prepared teeth prior to amalgam placement.

Device Story

iBond™ Gluma® inside is a dental resin bonding agent used by dentists in clinical settings. It functions as an adhesive interface between tooth structure and restorative materials (composite, compomer, Polyglas resins, or indirect restorations like porcelain). It also serves as a sealant for prepared teeth before amalgam placement. The device is applied by the clinician to the prepared tooth surface to facilitate bonding. It improves the retention and marginal integrity of dental restorations, benefiting patients by ensuring durable, long-term restoration performance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin-based dental bonding agent. Formulated for adhesion to tooth structure and various restorative materials. Applied via standard dental clinical procedures.

Indications for Use

Indicated for bonding composite, compomer, and Polyglas resins to tooth structure, cementing indirect restorations (e.g., Anglass, porcelain), and sealing prepared teeth prior to amalgam placement.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 8 2002

Ms. Cheryl Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re:. K022612

Trade/Device Name: iBond™ Gluma® inside Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 2, 2002 Received: August 6, 2002

Dear Ms. Zimmerman:

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 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.

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.

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## Page 2 - Ms. Zimmerman

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Jlatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K022612 510(k) Number (if Known):

Device Name: iBond™ Gluma® inside

Indications For Use:

Bonding composite, comporner and Polyglas® resins to the tooth structure as well for indirect restorations (e.g. Anglass®, procelain) and sealing of prepared teeth prior to amalgam placement.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use OR -(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Suan Qunny
(Division Sign-Off)

Division of Anesthesiology, General Ho Infection Control, Dental

510(k) Number: C022148