MODIFICATION TO ADPER PROMPT

K040857 · 3M Espe AG Dental Products · KLE · May 10, 2004 · Dental

Device Facts

• Record ID: K040857
• Device Name: MODIFICATION TO ADPER PROMPT
• Applicant: 3M Espe AG Dental Products
• Product Code: KLE · Dental
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling matcrials Bonding mediator for fissure sealing Desensitization of hypersensitive arcas of tecth

Device Story

Adper Prompt is a resin tooth bonding agent applied to prepared tooth cavities or exposed dentin surfaces. It functions by sealing dentinal tubules to reduce fluid movement, thereby preventing dentinal hypersensitivity and improving retention of restorative materials. The device is intended for professional use by dentists in a clinical setting. It is applied to the interior of a prepared cavity or onto exposed dentin. The clinical benefit is the reduction of patient sensitivity and improved bonding of restorative materials.

Clinical Evidence

Bench testing only. Performance and comparative testing were conducted to evaluate the device's ability to reduce fluid movement and prevent dentinal hypersensitivity. No clinical trial data was provided.

Technological Characteristics

Resin tooth bonding agent. Chemical composition is identical to the predicate device (K020946). No specific materials, energy sources, or software algorithms are described.

Indications for Use

Indicated for patients requiring dental bonding between dentin/enamel and composite or compomer filling materials, fissure sealing, or desensitization of hypersensitive tooth areas.

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.

Predicate Devices

• Adper Prompt by 3M ESPE (K020946)
• Gluma Comfort Bond + Desensitizer by Heraeus Kulzer (K992292)

Submission Summary (Full Text)

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# MAY 1 0 2004

K040857

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter

| Company: | 3M ESPE AG |
|------------------------------------|-----------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann,<br>Manager U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | March 30, 2004 |
| <b>Name of Device</b> | |
| Proprietary Name: | Adper Prompt |
| Classification Name: | Resin Tooth Bond Agent |
| Common Name: | Dental Adhesive |
| <b>Predicate Devices:</b> | |
| Adper Prompt by 3M ESPE | K 020946 |
| Gluma Comfort Bond + Desensitizer | K 992292<br>by Heraeus Kulzer |

,一次,一次, 510(k) Adper Prompt

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#### Description for the Premarket Notification

Adper Prompt is classified as Resin Tooth Bond Agent ( 21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer amd composite restorative material).

Additionally, as recent results show, Adper Prompt can be used to seal dentinal tubules of exposed dentin surfaces to prevent from dentinal hypersensitivity. 3M ESPE submits this 510(k) premarket notification to seek clearance for this new indication for use.

Performance and comparative testing of Adper Prompt has been carried out. The results suggest that Adper Prompt is a suitable agent to reduce fluid movement and to prevent from dentinal hypersensitivity.

The chemical composition of Adper Prompt remained unchanged in comparison to 510(k) K 020946. Performance data for Adper Prompt as a dental bonding agent are, therefore, not subject of this 510(k) submission.

The data provided in this 510(k) submission show that Adper Prompt is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2004

Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K040857

Trade/Device Name: AdperTM PromptTM Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: March 30, 2004 Received: April 07, 2004

Dear Dr. Petermann:

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.

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#### Page 2 - Dr. Andreas Petermann

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]. 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) you may obtain. 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.

Chido S. Nwafor, Ph.D.

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

Enclosure

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## Indications for Use

04085 510(k) Number (if known): Device Name: Adper Prompt, Adper Prompt L-Pop Indications For Use Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling matcrials Bonding mediator for fissure sealing Desensitization of hypersensitive arcas of tecth

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Susa Runoer

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number. K041657

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