K Number
K962065
Device Name
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
Manufacturer
Date Cleared
1996-07-18

(51 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
3M™ Vitrebond 114 Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations.
Device Description
3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties.
More Information

Not Found

No
The device description focuses on the chemical composition and physical properties of a dental liner/base material, with no mention of AI or ML technologies.

No
The device is described as a liner/base for dental restorations, indicating it's used to prepare the tooth for a filling, not to treat a disease or condition itself.

No
The device is described as a liner/base material for restorations, not for diagnosing conditions or diseases. Its function is to bond to tooth structure and release fluoride.

No

The device is a dental material comprised of powder and liquid components, 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 for "lining and basing applications under composite, amalgam, ceramic, and metal restorations." This describes a material used within the body (specifically, within a tooth) for structural and protective purposes during dental procedures.
  • Device Description: The description details a dental material (glass ionomer) that bonds to tooth structure and releases fluoride. This is consistent with a dental restorative or protective material, not a diagnostic test performed in vitro (outside the body).
  • Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological sample (like blood, urine, tissue, etc.) to provide information about a patient's health status or disease.

IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely related to the physical restoration and protection of tooth structure.

N/A

Intended Use / Indications for Use

3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations.

Product codes

dental cement other than zinc oxide-eugenol (21 CFR 872.3275(b))

Device Description

3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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

Not Found

Predicate Device(s)

Vitrabond Light Cure Glass Ionomer Liner (K882821), Bisco Cavity Cleanser (K915668), Uni-Etch™ (part of One-Step Universal Dentin Adhesive)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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 Dental Products Laboratory

3M Center, Building 260-2B-09 St. Paul, MN 55 (44-1000) 612 733 3149

K9620065

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

JUL 18 1996

| Name: | Amy E. Fowler
Senior Regulatory Affairs Associate |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3M Dental Products Laboratory
3M Center, Building 260-2B-09
St. Paul, MN 55144-1000 |
| Phone: | (612) 736-1590 |
| Fax: | (612) 736-0990 |
| Date: | May 24, 1996 |
| Trade Name: | 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base |
| Common Names: | cavity liner, lining cement, bonded base |
| Classification Name: | dental cement other than zinc oxide-eugenol
(21 CFR 872.3275(b)) |
| Predicate devices: | Vitrabond Light Cure Glass Ionomer Liner (K882821)
Bisco Cavity Cleanser (K915668)
Uni-Etch™ (part of One-Step Universal Dentin Adhesive) |

3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties. 3M™ Vitrebond 114 Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations.

3MM Vitrebond™ Light Cure Glass Ionomer Liner/Base has been changed very little since it was introduced globally over seven years ago. It is going through the 510(k) process now to add some labeling claims. In all other respects it is substantially equivalent to Vitrabond (K882821).

The toxiciology and histology data discussed in K882821 still applies, since the chemical composition is virtually unchanged. The fact that this material has been used globally for years with excellent results confirms the fact that this material is safe and effective for its intended uses.

3MTM Vitrebond™ Light Cure Glass Ionomer Liner/Base is substantially equivalent to the Bisco Cavity Cleanser (K915668) and Uni-Etch™ on the basis that they contact dentin and make a similar claim.