K Number
K111185
Device Name
RELYX LUTING PLUS AUTOMIX
Date Cleared
2011-05-05

(8 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

No
The document describes a dental cement and its physical properties and performance, with no mention of AI or ML technology.

No.
The device is a dental cement used for luting (bonding) various dental restorations and orthodontic appliances, which is a structural or supportive function rather than a therapeutic one.

No
The device is a dental cement used for luting, which is a restorative and bonding function, not a diagnostic one.

No

The device description clearly identifies the device as a physical dental cement consisting of pastes in a syringe, not software.

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

Here's why:

  • Intended Use: The intended use is clearly stated as a "dental cement" for luting various dental restorations and appliances to tooth structure. This is a direct application within the oral cavity for structural support and sealing.
  • Device Description: The description details a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. This is a material used for bonding and filling, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is the material being applied to the patient.

In summary, this device is a dental material used for direct application in the mouth, which falls outside the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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 .

Product codes

EMA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Bench Test Data Comparison with Substantially Equivalent, Currently Marketed Device. Properties tested include: Flexural strength (FS) (MPa) using ISO 9917-2; Radio-opacity (mm of Al) using ISO 9917-2; Adhesion to dentin (MPa) using 3M ESPE internal method; Adhesion to enamel (MPa) using 3M ESPE internal method; Adhesion to Metal (MPa) using 3M ESPE internal method; Adhesion to Lava™ (MPa) zirconia using 3M ESPE internal method; Adhesion to composites using 3M ESPE internal method; Adhesion to amalgam using 3M ESPE internal method; Adhesion to Titanium (MPa) using 3M ESPE internal method; Adhesion to Lithium disilicate (MPa) using 3M ESPE internal method; Fluoride release (µg F/g) at 90 days using 3M ESPE internal method; Film thickness (microns) using ISO 9917-2; Work time (s) using 3M ESPE internal method; Set time (s) using 3M ESPE internal method. All tested properties "pass" for both Lexus 2 Design Specification/Average and RelyX Luting Plus (predicate K022476).

Key Metrics

Flexural strength (FS): ≥ 10 MPa
Radio-opacity: ≥1.0mm of Al
Adhesion to dentin: ≥2 MPa
Adhesion to enamel: ≥2 MPa
Adhesion to Metal: ≥2 MPa
Adhesion to Lava™ zirconia: ≥2 MPa
Adhesion to composites: ≥2 MPa
Adhesion to amalgam: ≥2MPa
Adhesion to Titanium: ≥2 MPa
Adhesion to Lithium disilicate: ≥2 MPa
Fluoride release: ≥500 (µg F/g) at 90 days
Film thickness: ≤ 25 (microns)
Work time: ≥ 90s
Set time:

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.

0

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
3M ESPE Dental Products
3M Center, Bldg. 260-2A-11
St. Paul, MN 55144-1000 USA |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Bernardo M. Medellin J.D.
Regulatory Affairs Specialist
Phone: (651) 733-5718
Fax: (651) 737-9665
bmmedellin1@mmm.com |
| Date Summary was Prepared | March 31th, 2011 |
| Trade Name | RelyX TM Luting Plus Automix
Resin Modified Glass Ionomer Cement |
| Common Name(s) | Dental Cement, polymer based |
| Recommended Classification | Resin Modified Glass Ionomer Cement
(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.

1

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

Device
PropertiesMethodLexus 2
Design
SpecificationLexus2
Ave
andRelyX
Luting
Plus
(predicate
K022476)
Flexural strength (FS)
(MPa)ISO 9917-2≥ 10 MPapasspass
Radio-opacity (mm of
Al)ISO 9917-2≥1.0mm of
Alpasspass
Adhesion to dentin
(MPa)3M ESPE internal≥2 MPapasspass
Adhesion to enamel
(MPa)3M ESPE internal≥2 MPapasspass
Adhesion to Metal
(MPa)3M ESPE internal≥2 MPapasspass
Adhesion to Lava™
(MPa) zirconia3M ESPE internal≥2 MPapasspass
Adhesion to composites3M ESPE internal≥2 MPapasspass
Adhesion to amalgam3M ESPE internal≥2MPapasspass
Adhesion to Titanium
(MPa)3M ESPE internal≥2 MPapasspass
Adhesion to Lithium
disilicate (MPa)3M ESPE internal≥2 MPapasspass
Fluoride release (µg
F/g) at 90 days3M ESPE internal≥500passpass
Film thickness
(microns)ISO 9917-2≤ 25passpass
Work time (s)3M ESPE internal≥ 90spasspass
Set time (s)3M ESPE internal