UNO

K071131 · 3M Espe AG Dental Products · KLE · Jul 25, 2007 · Dental

Device Facts

• Record ID: K071131
• Device Name: UNO
• Applicant: 3M Espe AG Dental Products
• Product Code: KLE · Dental
• Decision Date: Jul 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

All classes of fillings (according to Black) with lightcuring composite or compomer Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE Core build-ups made of light-curing composite Root surface desensitization Repair of composite or compomer fillings Repair of restorations veneered with composite or ceramic Bonding orthodontic appliances to teeth for orthodontic treatment

Device Story

Uno is a resin tooth bonding agent applied to prepared tooth cavities to improve retention of restorative materials. It eliminates the need for a separate etching step, reducing application errors and post-operative sensitivity. The device is used by dentists in a clinical setting. It is based on methacrylate chemistry, making it suitable for bonding methacrylate-based composites to dentin and enamel. It is available in single-dose applicators or vials. The device is applied to the tooth surface to facilitate the adhesion of light-curing composites, compomers, or indirect restorations, and to seal sensitive root surfaces or bond orthodontic appliances. By simplifying the bonding procedure, it saves chair time for the practitioner and improves the clinical outcome for the patient.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through biocompatibility testing and comparison of chemical and performance characteristics to predicate devices.

Technological Characteristics

Resin tooth bonding agent based on methacrylate chemistry. Formulated for self-etching application (eliminating separate etching step). Available in single-dose applicators or vials. Compatible with light-curing composite and compomer restorative materials.

Indications for Use

Indicated for patients requiring dental restorative procedures, including all classes of cavity fillings, cementation of indirect restorations (composite, compomer, ceramic, metal), core build-ups, root surface desensitization, repair of existing restorations, and bonding of orthodontic appliances.

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 L-Pop by 3M ESPE (K060684)
• Prompt L-Pop by 3M ESPE (K001494)
• Hermes Bond 2 by 3M ESPE (K043043)
• RelyX Unicem by 3M ESPE (K020256)
• ESPE Sil by 3M ESPE (K913965)
• Sinfony by 3M ESPE (K992645)

Submission Summary (Full Text)

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# JUL 2 5 2007

4 510(k) Summary of Safety and Effectiver

# 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 Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | April 20, 2007 |

## Name of Device

| Proprietary Name: | Uno |
|----------------------|---------------------------|
| Classification Name: | Resin tooth bonding agent |
| Common Name: | Dental Adhesive |

### Predicate Devices

· ·

| Adper Prompt L-Pop by 3M ESPE | K060684 |
|-------------------------------|---------|
| Prompt L-Pop by 3M ESPE | K001494 |
| Hermes Bond 2 by 3M ESPE | K043043 |
| RelyX Unicem by 3M ESPE | K020256 |
| ESPE Sil by 3M ESPE | K913965 |
| Sinfony by 3M ESPE | K992645 |

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### Description for the Premarket Notification

Uno is classified 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).

Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel.

Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop.

Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop.

Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.

To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device.

The comparison for chemistry, performance data and indications for use shows that Uno is substantially equivalent to the predicate devices.

In summary, it can be concluded that safety and effectiveness requirements for Uno are completely met.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 5 2007

Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria GERMANY D-82229

Re: K071131

Trade/Device Name: Uno Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 27, 2007 Received: July 9, 2007

Dear Dr. Soegiarto:

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. Soegiarto

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]. 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 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/industry/support/index.html.

Sincerely yours.

Sustie Y. Michie, M.D.

Chiu Lin, Ph.D. 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

510(k) Number (if known):

Device Name:

Indications For Use:

Uno

- All classes of fillings (according to Black) with lightcuring composite or compomer
- Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE

- Core build-ups made of light-curing composite
- Root surface desensitization
- Repair of composite or compomer fillings
- Repair of restorations veneered with composite or ceramic
- Bonding orthodontic appliances to teeth for orthodontic treatment

Prescription Use (Part 21 OFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smith Michiano MD

( Mision Sign-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K0711.