(90 days)
Maxcem 2 (K073209)
Not Found
No
The 510(k) summary describes a dental cement and its physical properties and performance metrics, with no mention of AI or ML capabilities.
No.
This device is a dental cement used for the cementation of indirect restorations, core build-ups, and cementation of crowns to implants. It is a material used in a restorative process, not a device that treats or prevents a disease, injury, or condition, which is the definition of a therapeutic device.
No
The device is a permanent resin cement used for bonding indirect dental restorations and core build-ups, not for diagnosing conditions.
No
The device description clearly states it is a paste/paste formulation packaged in dual barrel syringes with automix tips, indicating it is a physical material (resin cement) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the cementation of dental restorations (inlays, onlays, crowns, bridges, posts, veneers, core build-ups, and crowns to implants). This is a therapeutic/restorative application, not a diagnostic one.
- Device Description: The description details a dental cement used for bonding materials within the mouth. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This device is a material used in a dental procedure.
N/A
Intended Use / Indications for Use
Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.
- Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.
- Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.
Nexus Universal and Nexus Universal Chroma are offered in paste/paste formulations for use as self-etch, self-adhesive resin cements or as bonded resin cements. These cements are considered permanent and not temporary.
The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration and/or tooth preparation.
Nexus Universal and Nexus Universal Chroma are offered in multiple shades. The difference between Nexus Universal and Nexus Universal Chroma is that Nexus Universal Chroma offers a gel-state color indicator, which visually displays the optimal time to remove the excess cement.
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
Licensed dental professionals
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)
Non-clinical performance data included testing for bond strength to various substrates, radiopacity, film thickness, diametral strength, consistency, amount of heat generated during setting, water sorption, dark-cure bond compatibility, and gel-state indicator color transition. Gel/set time testing and biocompatibility testing were also performed. The data analyzed from the various tests substantiate that the proposed Nexus Universal and Nexus Universal Chroma are substantially equivalent to the predicate, Maxcem 2 (K073209).
Clinical Performance Data: Clinical performance testing has not been performed for the proposed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Gel/Set Time (fresh ambient/ fresh oral): ≥ 2'00" / ≤ 3'30"
Bond Strength to Dentin: 23.05 MPa
Bonding strength for Post Cementation: 62.34 lbs
Radiopacity, % aluminum: 283%
Film Thickness: 24 μm
Diametral Strength, Mpa (Dual-Cure mode): 58.1 MPa
Consistency: 3.39 cm
Maximum Temperature During Self Curing: 26.89°C
Water sorption: 33.5 µg/mm³
Color at set time: Pass
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Maxcem 2 (K073209)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2015
Sybron Dental Specialties Ms. Courtney Clark Regulatory Affairs Manager 1717 W. Collins Avenue Orange, CA 92867
Re: K151332
Trade/Device Name: Nexus Universal, Nexus Universal Chroma Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 18, 2015 Received: May 19, 2015
Dear Ms. Clark:
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: CDRH 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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151332 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Device Name
Nexus Universal/ Nexus Universal Chroma
Indications for Use (Describe)
Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.
- Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5. 510(k) SUMMARY for Nexus Universal / Nexus Universal Chroma
Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized, bold, blue font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, less bold font, also in blue.
Nexus Universal /Nexus Universal Chroma
- Submitter Information: 1. Sybron Dental Specialties
1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Courtney Clark |
|---|---|
| Telephone Number: | 714-516-7426 |
| Fax Number: | 714-516-7472 |
Date Prepared: May 18, 2015
-
- Device Name:
- Proprietary Name: Nexus Universal and Nexus Universal Chroma .
- . Classification Name: Dental Cement w/out Zinc-Oxide Eugenol
Cement, Dental
- 872.3275 CFR Number: ●
- Device Class: II .
- Product Code: EMA .
-
- Predicate Device:
The proposed Nexus Universal and Nexus Universal Chroma are substantially equivalent to the legally marketed predicate device. Maxcem 2 (K073209), cleared on January 29, 2008, product codes MZW, EMA.
-
- Description of Device:
Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.
- Description of Device:
- Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.
4
Nexus Universal and Nexus Universal Chroma are offered in paste/paste formulations for use as self-etch, self-adhesive resin cements or as bonded resin cements. These cements are considered permanent and not temporary.
The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration and/or tooth preparation.
| Accessories Used with Nexus
| Universal / Nexus Universal Chroma | Manufacturer of Accessory |
|---|---|
| Dual barrel syringe | Sulzer Mixpac AG |
| Ruetistrasse 7 | |
| Haag Sankt gallen, Switzerland 9469 | |
| Curved dispensing tips | Sulzer Mixpac AG |
| Ruetistrasse 7 | |
| Haag Sankt gallen, Switzerland 9469 | |
| Auto-mix tips | Sulzer Mixpac AG |
| Ruetistrasse 7 | |
| Haag Sankt gallen, Switzerland 9469 |
Nexus Universal and Nexus Universal Chroma are offered in multiple shades. The difference between Nexus Universal and Nexus Universal Chroma is that Nexus Universal Chroma offers a gel-state color indicator, which visually displays the optimal time to remove the excess cement.
న. Statement of Indications for Use:
Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.
- Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.
6. Description of Substantial Equivalence:
Technological Characteristics
Nexus Universal and Nexus Universal Chroma, like their predicate Maxcem 2 (K073209), are self-adhesive paste/paste dual-cure permanent resin cements. Thev provide a simplified one-step cementation procedure by combining the etching, priming, bonding and cementing steps into a single step. This is achieved by incorporating adhesive monomers along with an acid tolerant redox initiator system into a traditional resin cement.
There are two curing mechanisms associated with the proposed Nexus Universal and Nexus Universal Chroma self-adhesive resin cements: self-curing (also referred to as dark-curing) mechanism by a redox initiator system and light-curing by a photoinitiator.
5
The proposed Nexus Universal and Nexus Universal Chroma offer the following changes over the predicate, Maxcem 2 (K073209):
-
- A gel-state color indicator (Nexus Universal Chroma only) provides clinicians with a visual cue indicating the optimal timing to remove the gelled excess cement
-
- Increased bond strength to dentin
-
- Increased bond compatibility with adhesive even in self-cure mode (also referred to as dark-cure mode)
The proposed Nexus Universal Chroma has a gel-state indicator that is a redox color indicator that has an initial pink color for the mixed paste before gelation. The pink color will fade away once the mixed paste reaches the gel state, the ideal timing for removing excess cement. For both the Nexus Universal and Nexus Universal Chroma, the increased bond strength to dentin and the increased bond compatibility with the adhesive in self-cure mode is achieved by modifying the adhesive property of the resin matrix and wetting ability of the pastes along the acid tolerant redox initiator system used in the proposed.
Non-Clinical Performance Data
Non-clinical performance data included testing for bond strength to various substrates, radiopacity, film thickness, diametral strength, consistency, amount of heat generated during setting, water sorption, dark-cure bond compatibility, and gel-state indicator color transition.
Gel/set time testing and biocompatibility testing were also performed. The data analyzed from the various tests substantiate that the proposed Nexus Universal and Nexus Universal Chroma are substantially equivalent to the predicate, Maxcem 2 (K073209). The following standards were utilized for the non-clinical performance testing of the proposed:
- ISO 10993-1: 2009 Biological evaluation of medical devices
- ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for ● Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in ● Vitro Cytotoxicity
- ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices- Part 11: Tests for System Toxicity
- . ISO 4049: 2009 Dentistry - Polymer-Based Restorative Materials
Additional testing was performed as recommended by the following guidance document:
- . FDA "Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification"
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Table 5.1: Predicate and Proposed Device Comparison Table
| Element | Predicate Device- Maxcem 2 | Nexus Universal/Nexus
Universal Chroma, Dental
Cement |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Maxcem 2 (K073209) | To be assigned |
| Trade Name | Maxcem 2, Dental Cement | Nexus Universal and Nexus
Universal Chroma, Dental Cement |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Indications for Use | Maxcem 2 is intended for
cementation of indirect restorations
including ceramic, resin and metal-
based inlays, onlays, crowns, bridges,
posts, and veneers.* Additional
indications include core-buildup
material, pit and fissure sealant, and
cementation of crown restorations to
implants.
Adhesive application on the prep is
required for veneer cementation
using Maxcem 2. | Nexus Universal/Nexus Universal
Chroma is indicated for
cementation of all indirect
restorations including ceramic,
resin, and metal-based
inlays/onlays, crowns, bridges,
posts, and veneers. Additional
indications include core build-ups
and cementation of crowns to
implants.
*Adhesive application on the
preparation is required for veneer
cementation using Nexus
Universal and Nexus Universal
Chroma. |
| Common Name | Dental Cement | Dental Cement |
| Classification Name | Cement, Dental, per 21 CFR §
872.3275(b) | Cement, Dental, per 21 CFR §
872.3275(b) |
| Class | II | II |
| Product Code | MZW/EMA | MZW/EMA |
| Storage | Ambient Temperature | Ambient Temperature |
| Curing Mechanism | Photo initiation or self-cure | Photo initiation or self-cure |
| Material Compatibility | Biocompatibility meets requirements | Biocompatibility meets
requirements |
| Shelf Life | 18 months based on real time data | 18 months based on accelerated
data |
| Gel/Set Time
(fresh ambient/ fresh
oral) | ≥ 2'00" / ≤ 3'30" | ≥ 2'00" / ≤ 3'30" |
| Bond Strength to
Dentin | 20.35 MPa | 23.05 MPa |
| Bonding strength for
Post Cementation | 59.68 lbs | 62.34 lbs |
| Radiopacity, %
aluminum | 280% | 283% |
| Film Thickness (μm) | 22 μm | 24 μm |
| Diametral Strength,
Mpa (Dual-Cure
mode) | 54.8 MPa | 58.1 MPa |
| Consistency | 3.00 cm | 3.39 cm |
| Maximum
Temperature During
Self Curing | N/A | 26.89°C |
| Water sorption | N/A | 33.5 µg/mm³ |
| Color indicator version
(Nexus Universal
Chroma): | N/A | |
| Color at set time | N/A | Pass |
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Clinical Performance Data
Clinical performance testing has not been performed for the proposed devices.
Conclusion as to Substantial Equivalence
The slight modifications to the formula of the predicate, Maxcem 2 (K073209), to increase bond strength and bond compatibility with the adhesive in self-cure mode, and add the gel-state color indicator (Nexus Universal Chroma only) shall not affect the safety or efficacy of the proposed devices based on internal performance testing and biocompatibility testing. Nexus Universal and Nexus Universal Chroma are substantially equivalent to the predicate, Maxcem 2 (K073209), based on formulation, performance and testing comparisons.