K Number
K071131
Device Name
UNO
Date Cleared
2007-07-25

(93 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

No
The device description and performance studies focus on the chemical composition and bonding properties of a resin tooth bonding agent, with no mention of AI or ML technologies.

No
The device is a bonding agent used in dentistry for restorative purposes and bonding orthodontic appliances, not for treating diseases or conditions.

No

The device description and intended use indicate that Uno is a resin tooth bonding agent used for dental restorations and bonding orthodontic appliances. Its function is to improve retention of restorative materials and seal sensitive root surfaces, which are therapeutic and restorative actions, not diagnostic.

No

The device description clearly states that Uno is a "Resin Tooth Bonding Agent" and describes its chemical composition and physical form (single dose applicators and vial version), indicating it is a physical substance, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's teeth (fillings, cementation, core build-ups, desensitization, repairs, bonding orthodontic appliances). These are therapeutic and restorative actions, not diagnostic tests performed on samples taken from the body.
  • Device Description: The description clearly states it's a "Resin Tooth Bonding Agent" intended to be painted on the interior of a prepared cavity of a tooth. This is a material applied directly to the patient's anatomy.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

Indications For 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

Product codes

KLE

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth/Teeth, Root surfaces

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K060684, K001494, K043043, K020256, K913965, K992645

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.3200 Resin tooth bonding agent.

(a)
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.(b)
Classification. Class II.

0

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 Number9611385
Official Correspondent:Dr. Andreas Petermann,
Manager Regulatory Affairs
Phone:011-49-8152-700 1395
Fax:011-49-8152-700 1869
E-mail:Andreas.Petermann@mmm.com
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 ESPEK060684
Prompt L-Pop by 3M ESPEK001494
Hermes Bond 2 by 3M ESPEK043043
RelyX Unicem by 3M ESPEK020256
ESPE Sil by 3M ESPEK913965
Sinfony by 3M ESPEK992645

1

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.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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.

3

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

4

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

Page 1 of

510(k) Number: K0711.