ADPER PROMPT

K020946 · 3M Espe AG Dental Products · KLE · Apr 4, 2002 · Dental

Device Facts

• Record ID: K020946
• Device Name: ADPER PROMPT
• Applicant: 3M Espe AG Dental Products
• Product Code: KLE · Dental
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bonding between dentin/enamel and composite filling materials. Bonding between dentin/enamel and compomer filling materials. Bonding mediator for fissure sealing. Bonding mediator for bracket attachment.

Device Story

Adper Prompt is a resin tooth bonding agent applied to the interior of a prepared tooth cavity to improve retention of restorative materials. It is available in two formats: a single-dose applicator system (Adper Prompt L-Pop) and a two-vial system. The device is applied by a dental professional in a clinical setting. It functions by chemically bonding dentin and enamel to composite or compomer restorative materials, fissure sealants, or orthodontic brackets. The device is a modification of the predicate Prompt L-Pop, featuring minor changes in chemical composition while maintaining the same basic chemical design and performance characteristics.

Clinical Evidence

No clinical data. Safety and effectiveness were established through comparative chemical analysis and independent biocompatibility testing.

Technological Characteristics

Resin tooth bonding agent (21 CFR 872.3200). Available as single-dose applicators or two-vial system. Chemical composition modified from predicate but maintains same basic chemical design. Class II device.

Indications for Use

Indicated for use as a dental bonding agent between dentin/enamel and composite or compomer filling materials, as a bonding mediator for fissure sealing, and as a bonding mediator for bracket attachment.

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

• Prompt L-Pop

Submission Summary (Full Text)

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K020946

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.

# Submitter

APR 0 4 2002

| Company: | 3M ESPE AG |
|------------------------------------|----------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann<br>Manager U.S. Regulatory Affairs |
| Phone: | 01149-8152-700 1395 |
| Fax: | 01149-8152-700 1869 |
| E-mail: | [e-mail] |
| Date of Submission: | March 22, 2002 |

Name of Device

| Proprietary Name: | Adper Prompt |
|----------------------|---------------------------|
| Classification Name: | Resin Tooth Bonding Agent |

Common Name: .................................................................................................................................................................

## Predicate Device:

Prompt L-Pop .................................................................................................................................................................

Description for the Premarket Notification

Adper Prompt is classified as a Resin Tooth Bonding 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 and composite restorative material).

Image /page/0/Picture/10 description: The image shows the text "Special 510(k) Adper TM Prompt TM" at the top. Below that is the text "3M ESPE" in a larger, bold font. The text is black and the background is white. The image appears to be a logo or product name.

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3M ESPE is submitting this Special 510(k) for modifications to the All-In-One Adhesive Prompt L-Pop.

The modifications of Prompt L-Pop concern minor changes of the chemical composition, however, the basic chemical design remains the same.

Like Prompt L-Pop, Adper Prompt will be available in single dose applicators, "Adper Prompt L-Pop". Additionally, Adper Prompt will also be available in a two-vial version called "Adper Prompt". The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics.

The modified bonding agent Adper Prompt has the following similarities to the unmodified Prompt L-Pop:

- . Adper Prompt has the same intended use.
- . Adper Prompt incorporates the same basic chemical design.
- . Adper Prompt has the same shelf life.

To provide evidence for safety, the chemical composition of Adper Prompt was compared to Prompt L-Pop. Additionally, an independent research institute carried out biocompatibility testing. The results show that Adper Prompt is a safe device.

To prove the effectiveness of Adper Prompt, the performance characteristics of Adper Prompt were compared to Prompt L-Pop.

In summary, the modified dental adhesive Adper Prompt described in this Special 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.

Image /page/1/Picture/10 description: The image shows the logo for 3M ESPE. The logo is in black and white. Above the logo, the text "Special 510(k) Adper TM Prompt TM" is written in a smaller font.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 0 4 2002

Re: K020946

Trade/Device Name: Adper Prompt Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: March 22, 2002 Received: March 25, 2002

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. Petermann

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dris assumes a your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any I ederal statutes and regulations and admited to: registration and listing (21 Comply with an the 10th 010th 2011); good manufacturing practice requirements as set CI'N in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by bound (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) I mis icher will anow you to begin maing of substantial equivalence of your device to a legally premits to the are in the Pressification 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 If you desire specific arr 809.10 for in vitro diagnostic devices), please contact the Office of adminity 21 OF F F art For 613. Additionally, for questions on the promotion and advertising of Compinance at (301) 591 to the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entities, "Thisoftanang on your responsibilities under the Act may be obtained from the Other general information 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,
Ky Whitlock

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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# STATEMENT OF INDICATIONS FOR USE

(As Required by 21 C.F.R. § 801.109)

K020946

510(k) Number:

Device Name:

Adper Prompt

Indications for use:

Bonding between dentin/enamel and composite filling materials.

Bonding between dentin/enamel and compomer filling materials.

Bonding mediator for fissure sealing

Bonding mediator for bracket attachment

Division Sign Off

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

Prescription use: □

Over-the counter use □