RELYX LUTING PLUS AUTOMIX

K111185 · 3M Espe Dental Products · EMA · May 5, 2011 · Dental

Device Facts

• Record ID: K111185
• Device Name: RELYX LUTING PLUS AUTOMIX
• Applicant: 3M Espe Dental Products
• Product Code: EMA · Dental
• Decision Date: May 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting: - Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups; - Luting metal inlays, onlays or crowns; - Luting pre-fabricated and cast post cementation - Luting orthodontic appliances - Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram

Device Story

RelyX Luting Plus Automix is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. It is supplied as a two-paste system (base and catalyst) in a dual-barrel automix syringe. Used by dental professionals in a clinical setting to cement various dental restorations (crowns, bridges, inlays, onlays, posts, orthodontic appliances) to tooth structure or core build-up materials. The device is self-curing, with an optional tack light-cure feature for excess cement removal. By providing a stable, adhesive bond between the restoration and the tooth, it secures the dental prosthesis, potentially improving patient oral function and restoration longevity.

Clinical Evidence

Bench testing only. Performance compared to predicate using ISO 9917-2 and internal 3M ESPE methods. Metrics included flexural strength (≥10 MPa), radio-opacity (≥1.0mm Al), adhesion to various substrates (dentin, enamel, metal, zirconia, composites, amalgam, titanium, lithium disilicate; all ≥2 MPa), fluoride release (≥500 µg F/g at 90 days), film thickness (≤25 microns), work time (≥90s), and set time (<480s). All specifications met.

Technological Characteristics

Resin-modified glass ionomer cement. Dual-barrel automix syringe delivery. Self-curing with optional light-cure for excess removal. Radiopaque and fluoride-releasing. Complies with ISO 9917-2 for dental water-based cements and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for luting porcelain-fused-to-metal crowns/bridges, metal inlays/onlays/crowns, pre-fabricated/cast posts, orthodontic appliances, and all-alumina or all-zirconia core crowns (e.g., Procera AllCeram) to tooth structure, amalgam, composite, or glass ionomer core build-ups.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• 3M ESPE RelyX Luting Plus Cement (K022476)

Submission Summary (Full Text)

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3M ESPE Dental Products

Image /page/0/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white, with the words "3M ESPE" in a bold, sans-serif font. The letters are evenly spaced and the logo is well-defined. The logo is simple and recognizable.

3M Center St. Paul, MN 55144-1000 651 733 1110

KIIII85

MAY - 5 2011

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Submitter | 3M Company<br>3M ESPE Dental Products<br>3M Center, Bldg. 260-2A-11<br>St. Paul, MN 55144-1000 USA |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Bernardo M. Medellin J.D.<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary was Prepared | March 31th, 2011 |
| Trade Name | RelyX ^TM Luting Plus Automix<br>Resin Modified Glass Ionomer Cement |
| Common Name(s) | Dental Cement, polymer based |
| Recommended Classification | Resin Modified Glass Ionomer Cement<br>(21 CFR 872.3275, Product Code: EMA) |
| Predicate Devices: | 3M ^TM ESPE ^TM RelyX ^TM Luting Plus Cement (K022476) |

### Description of Device:

3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.

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### Indications for Use:

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:

- Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or . glass ionomer core build ups;
- . Luting metal inlays, onlays or crowns;
- Luting pre-fabricated and cast post cementation .
- . Luting orthodontic appliances
- Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram .

### Substantial Equivalence:

Information provided in this 510(k) summary shows that the product is substantially equivalent to 3M ESPE's predicate device, RelyX™ Luting Plus Cement (K022476).

| Bench Test Data Comparison with Substantially Equivalent, Currently Marketed<br>Device | | | | |
|----------------------------------------------------------------------------------------|------------------|------------------------------------|----------------------|---------------------------------------------------|
| Properties | Method | Lexus 2<br>Design<br>Specification | Lexus2<br>Ave<br>and | RelyX<br>Luting<br>Plus<br>(predicate<br>K022476) |
| Flexural strength (FS)<br>(MPa) | ISO 9917-2 | ≥ 10 MPa | pass | pass |
| Radio-opacity (mm of<br>Al) | ISO 9917-2 | ≥1.0mm of<br>Al | pass | pass |
| Adhesion to dentin<br>(MPa) | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to enamel<br>(MPa) | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to Metal<br>(MPa) | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to Lava™<br>(MPa) zirconia | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to composites | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to amalgam | 3M ESPE internal | ≥2MPa | pass | pass |
| Adhesion to Titanium<br>(MPa) | 3M ESPE internal | ≥2 MPa | pass | pass |
| Adhesion to Lithium<br>disilicate (MPa) | 3M ESPE internal | ≥2 MPa | pass | pass |
| Fluoride release (µg<br>F/g) at 90 days | 3M ESPE internal | ≥500 | pass | pass |
| Film thickness<br>(microns) | ISO 9917-2 | ≤ 25 | pass | pass |
| Work time (s) | 3M ESPE internal | ≥ 90s | pass | pass |
| Set time (s) | 3M ESPE internal | <480s | pass | pass |

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Environmental, health and safety (EHS) risks for RelyX™ Luting Plus Automix were evaluated using a process compliant with ISO14971:2007, Medical Devices - Application of Risk Management to Medical Devices and with specific procedures and practices outlined by 3M ESPE's Standard Operating Procedures. The conclusion of the risk assessment is that the product RelyX™ Luting Plus Automix is safe for its intended use.

A biocompatibility assessment was developed for this new product using ISO 10993-1:2009(E) Biological evaluation of medical devices.Testing included Genotoxicity, cytotoxicity, sensitization, and systemic toxicity. The conclusion of the assessment is that the product RelyX™ Luting Plus Automix is safe for its intended use.

Combined with biocompatibility testing, based on a comparison of intended use and indications for use, contraindications, physical properties, and composition, 3M ESPE concludes that RelyX™ Luting Plus Automix is substantially equivalent to the named predicate device RelyX™ Luting Plus Cement (K022476). No new concerns about safety or effectiveness have been identified.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

3M ESPE Dental Products C/O Mr. Bernardo Medellin Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAY - 5 2011

Re: K111185

Trade/Device Name: RelyX Luting Plus Automix - Resin Modified Glass Ionomer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 26, 2011 Received: April 27, 2011

Dear Mr. Medellin:

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. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Medellin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jamshed Dastoor

for

Anthony D. Watson, B.S., M.S., M.B.A. 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: RelyX™ Luting Plus Automix - Resin Modified Glass Ionomer Cement

### Indications for Use:

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix

(Lexus-2) is indicated for Luting:

- Luting porcelain fused to metal crowns and . bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
- Luting metal inlays, onlays or crowns; .
- Luting pre-fabricated and cast post cementation .
- Luting orthodontic appliances .
- Luting crowns made with all-alumina or all zirconia . cores such as Procera® AllCeram

Prescription Use _______ X (Part 21 CFR 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 OF NEEDED)

. '

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Purser
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111185

RelyX™ Luting Plus Automix Resin Modified Glass lonomer Cement 510(k) 3M ESPE Dental Products Confidential Appendix 8